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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error

Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+blood glucose test strips with the Taidoc meters which could result in incorrect glucose results.

Falsely high or falsely low glucose results could potentially cause missed or delayed hyperglycemia or hypoglycemia detection and lead to no treatment or inappropriate treatment. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states could lead to serious health consequences, including death.

Diabetic Supply of Suncoast, Inc. is notifying its wholesale Distributors, Pharmacies, Medical Supply stores, Health Care Providers and direct customers throughout the entire US and Virgin Islands by letter and Press Release about the specifics of the recall.

Customers who have the affected test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information. Test strips will be replaced with relabeled boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned test strips and contact Suncoast to find out if this recall pertains to the test strips they have in their possession and if so how to have them replaced for the relabeled products manufactured by BroadMaster Bio-Tech.

Customers with questions may contact Diabetic Supply of Suncoast at (561) 296-0488 between the hours of 9:00AM and 5:00PM Monday through Friday Eastern standard time.

Customers who have the Advocate Redi-Code blood glucose meters manufactured by Taidoc Technology Corp should follow the product User Manual for information about the appropriate test strips to be used with the Taidoc meters.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates

Alexion Pharmaceuticals, Inc. announced that it is initiating a voluntary recall of certain lots of Soliris (eculizumab) 300mg/30 mL concentrated solution for intravenous infusion. The administration of particulate, if present in a parenteral drug, poses a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening. The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.

Soliris is approved as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product from the identified lots was last shipped on October 30, 2013, there is anticipated to be little, if any, material from these lots still remaining in commercial distribution.

Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately by calling 1-888-SOLIRIS (888-765-4747), Monday-Friday from 8:30am to 5:00pm Eastern Time (ET). Alexion is notifying its distributors and customers by letter being sent via Federal Express and is arranging for replacement of all recalled products.

Healthcare professionals and pharmacists with questions regarding this recall can contact Alexion at 1-888-765-4747, Monday-Friday from 8:30am to 5:00pm ET. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Unaffected lot numbers can continue to be used according to the instructions for use.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage

ASP has notified the FDA of a critical shortage of Sterrad Cyclesure 24 Biological Indicators due to a machine performance issue on its production line.  ASP is able to ship only 30 percent of its normal capacity for the Sterrad Cyclesure 24 Biological Indicator.

ASP expects to increase production by July 2014 and anticipates being able to meet the full product demand by August 2014.

The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used with Sterrad sterilizers to monitor and confirm the effectiveness of the device sterilization process. The FDA does not have safety concerns about the Sterrad sterilizers, which are used for heat-sensitive medical devices that must be sterilized at low temperatures and low moisture, such as flexible endoscopes, cameras, some rigid scopes, light cords, batteries, and power drills.

Use an alternative low-temperature sterilizer, if available. When possible, prioritize using Sterrad Cyclesure 24 Biological Indicators for sterilization loads that contain the most critical instruments for the most urgent patient cases. See the FDA Safety Communication for additional information and recommendations.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy

AUDIENCE: Risk Manager, Nursing, Biomedical Engineer

ISSUE: Fisher & Paykel Healthcare received 24 reports in which the affected prongs detached from the nasal tubing during use, especially when mucous and/or moisture are present. When the affected prongs detach from the nasal tubing, therapy is likely to be interrupted. This may cause low blood oxygen (hypoxemia). The detached prongs may enter an infant’s mouth and present a potential risk of choking and airway obstruction. The use of the affected product may cause serious adverse health consequences, including death.

The Nasal CPAP Prongs connect to the Fisher and Paykel Healthcare FlexiTrunk Patient Interface. The prongs are placed in the patient’s nostrils to deliver continuous positive airway pressure (CPAP) which involves passing air through an infant’s nose. The prongs are used in patients weighing up to 22 pounds in a hospital or clinical setting where the patient is monitored by trained medical staff. The device is not intended to be used as a life supporting device.

RECOMMENDATION: Starting April 11, 2014, Fisher & Paykel Healthcare sent its customers an Urgent Medical Device Recall letter. The letter identified the product, problem, and actions to be taken, which include:

  • Identify any Affected Prongs in your inventory by checking the REF and LOT number on the packaging. For Starter Kits, only the Nasal CPAP Prongs are affected and the rest of the Starter Kit is suitable for use.
  • Destroy the Affected Prongs by cutting them in half and disposing of the products.
  • Complete Section A ‘Inspection of Stock’ on the Urgent Medical Device Recall Response Form and return it to your FPH Representative.
  • Contact your FPH Representative for replacement products.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk

ISSUE: Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). Bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely.

The affected lots are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.

Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity (salt concentration).


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms

Including ABACUS Total Parenteral Nutrition Calculation Software, v3.1, v3.0, v2.1, and v2.0. 

FDA notified health professionals of a Class I Recall due to software failures when using ABACUS TPN calculation software. If any of these failures were to occur, patients may be at risk for toxic or overdose symptoms. Symptoms may be non-specific and include nausea, vomiting, dizziness or fatigue. Some more severe symptoms include a problem with the rate or rhythm of the heartbeat (cardiac arrhythmia), an abnormal buildup of fluid in the air sacs of the lungs, which leads to shortness of breath (pulmonary edema), congestive heart failure and seizures. A fatal outcome is possible, especially with the high risk population.

The affected software was manufactured from May 17, 2006 through May 28, 2013 and distributed from May 17, 2006 through March 17, 2014. Affected product codes can be found in the FDA Recall Notice. 

BACKGROUND: ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas. TPN is used to meet the nutritional needs of patients who cannot eat or drink by mouth and is used in the hospital or in the home by a licensed health care professional.

On April 21, 2014, Baxter sent an Urgent Device Correction letter to all affected customers. Baxter’s letter directed customers to contact Baxter to ensure that the ABACUS software is configured correctly. Customers with a software version earlier than 3.1 will have software version 3.1 installed that addresses the issues in the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.

Baxter also requested that its customers take specific actions, which can be found in the FDA Recall Notice.

Health care professionals: For questions about the actions to be taken, contact Baxter Technical Support at 1-800-678-2292, Monday through Friday, 6 am - 5 pm, Mountain.  For questions about the recall, contact Baxter at 303-617-2242.

Patients having this procedure at home: For questions about this recall, contact your home health care agency or doctor.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall - Failure of Fan Assembly

Including System 98/98XT, CS100/CS100i, and CS300, Model Numbers:  0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx, 0998-UC-0446Hxx, 0998—00-3013-xx, 0998-UC-3013-xx, 0998-00-3023-xx, 0998-UC-3023-xx; and various lot numbers

FDA notified health professionals of a Class I Recall due to a fan assembly for the affected Intra-Aortic Balloon Pumps (IABP) that could contain a misshapen retaining ring. This retaining ring could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning.

This device failure would cause the balloon to stop inflating and deflating. It may result in decreased blood flow to the heart and the rest of the body, difficulty in weaning the patient from cardiopulmonary bypass, and clotting or blockage of blood vessels to the intestines, kidneys, or legs. The possible long range consequences of this include organ injury or tissue damage, possibly leading to patient death.

Affected products were manufactured From January 1, 2003 through June 30, 2011 and distributed from January 17, 2003 through June 30, 2011.

An intra-aortic balloon pump is a mechanical device that inflates a balloon placed in the patient’s thoracic aorta. The balloon inflates and deflates in order to help the heart pump blood, increase blood flow to the heart itself, and increase blood flow to the rest of the body.  The device is used temporarily for emergency cardiac support conditions, such as after a heart attack, for severe heart failure, or while the patient is waiting for heart surgery.

On March 21, 2014, Maquet sent an Urgent Medical Device Field Correction letter to all affected customers. The letter identified the product, the problem, and the actions to be taken.

A recalled pump may continue to be used until a repair or replacement is performed. However, there should be heightened awareness that a sudden pump failure may occur without warning, and a backup pump should be available for immediate substitution in the case of a failure. If an alternative pump is unavailable and a failure occurs, the balloon should be removed from the patient as soon as possible according to standard procedures.  This could result in added risk to the patient.

A Maquet Service Representative will contact customers with the affected IABPs to replace the fan assembly. For customers with technical questions within the U.S., contact Technical Support at 1-800-777-4222 and press 3, Monday through Friday, between 8:00 a.m. and 6:00 p.m., Eastern Daylight Time.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion

CareFusion is recalling the Alaris Pump model 8100, version 9.1.18, because the pump may have a software failure where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. This issue does not impact the “Delay For” Option. The software failure also causes the pump to not properly deliver a multidose infusion as expected under certain conditions.

Infusion start times earlier or later than intended could result in serious injury or death.

The Alaris Pump Model 8100 is a large volume infusion pump. The affected products were manufactured from February 6, 2014 to April 8, 2014 and distributed from February 7, 2014 through April 7, 2014. See the FDA recall notice for a listing of the affected serial numbers.

The firm recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. CareFusion will contact all affected customers to schedule the installation of software version 9.1.17. Do NOT use the Alaris Pump module “Delay Until” option. Do NOT use the “Multidose” feature.

As an interim guidance, customers may update their dataset to disable both Delay Options and/or Multidose across all Profiles to prevent the use of “Delay Until” option and/or “Multidose” feature. These are shared configurations with the Alaris Syringe module and if disabled would prevent use of these features with the Alaris Syringe module as well.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates

Hospira, Inc. will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. The recall is due to embedded particulate within the glass vial and visible particles floating in the solution. There is the potential for product to come into contact with embedded particles and the particles may become dislodged into the solution. The embedded particulate was identified as stainless steel and the floating particulate as iron oxide.

Blocked administration of the drug to the patient, causing a delay in therapy is possible. However, due to the size of the particulates identified, it is more likely that particulates are able to pass through the catheter and may cause injection site reactions and local irritation in the blood vessels, tissues and organs. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

Labetalol Hydrochloride Injection, USP is a clear colorless solution for intravenous administration and is indicated for control of blood pressure in severe hypertension. The recalled lot was distributed nationwide in the U.S. in February, 2014, to wholesalers/distributors, hospitals and clinics.

Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. For additional assistance, call Stericycle at 1-888-386-2076 (M-F, 8 a.m - 5 p.m. ET). For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment

Including Lunesta and generics

FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. FDA approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.

A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired.  The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. 

Health care professionals should follow the new dosing recommendations when starting patients on Lunesta. Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them. FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates

Hospira, Inc. issued a nationwide recall to the user level for one lot of Dobutamine Injection, USP, 250 mg, 20 mL, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. (NDC and lot number can be found on the right-hand side of the primary label). This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through September 2013.

Risk factors associated with particulate and/or a glass defect include the potential for particulate to be injected, a breach of sterility/contamination of the vial contents, leakage of contents, and/or a delay in therapy.  In general, injected particulate matter may result acutely in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. If contaminated solution is used on a patient, this may potentially cause bacteremia, sepsis, septic shock and endocarditis, and death may result. Leakage may result in drug wastage, spillage onto equipment, flooring and personnel.  If a defective vial is not detected until the point of care, there may be a delay in therapy.

The recall was due to a confirmed customer report of discolored solution. Upon review of the complaint, a chip in the glass at the neck of the vial was identified as well as glass particulate within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Dobutamine should be considered a potent drug and potentially irritating to eyes and respiratory tract. Users should avoid liquid aerosol generation and skin contact.

For additional assistance, call Stericycle at 1-877-907-9956 (M-F, 8 a.m - 5 p.m. ET).

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.  Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF).


Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory

Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.  Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths.

The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result.  

Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.

Healthcare professionals should immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer. 


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies

AUDIENCE: Risk Manager, Biomedical Engineer, Nursing

ISSUE: Hospira received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to the patient. If the door assembly breaks, it may prevent the door from closing properly and an over-infusion or a delay of therapy may occur. If the door cannot be closed, the pump cannot be used which can result in a delay of therapy.

Use of these affected products may cause serious adverse health consequences, including death.

Affected Abbott Acclaim Infusion Pumps, list Number 12032 were manufactured from February 1998 to November 1998 and distributed from September 1998 through February 2004. Affected Hospira Acclaim Encore infusion pumps list Number 12237 were manufactured from February 1997 to February 2010 and distributed from July 1999 through November 2013.

Hospira recommends that users inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks, prior to programming a therapy, by following the steps outlined below:

1. After inserting the tubing (with the roller clamp closed) and closing the door handle against the infusion pump, check that the door is fully closed.

  • If a pump has a door that does not close properly, and a gap or separation exists between the completely closed door and the pump itself, remove the pump from clinical service and call Hospira.
  • For pumps where the door closes correctly, proceed to Step 2.

2. For pumps with the door closing correctly, and a gap or separation does not exist between the completely closed door and the pump itself, check that there is no free flow activity in the drip chamber of the administration set by opening the roller clamp.

  • If free flow is detected, close the roller clamp, remove the pump from clinical service and call Hospira.

3. If no issues are found through steps 1 and 2, the pump is deemed acceptable for use. Additionally, please take the following actions related to this safety notification:

  1. Ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.
  2. Complete the reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. Contact Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to obtain additional copies of the reply form, if needed.
  3. If you have further distributed the Hospira/Abbott Acclaim Encore infusion pumps, please notify your customers who may have received these infusion pumps from you and ask them to contact Stericycle at 1-866-891-0586 (M-F, 8am-5pm, ET) to receive a reply form.

Product Correction:

After following the instructions above, if you determine that a pump has a door that does not close correctly or if free flow is detected while the administration set is in the pump with the door closed, close the roller clamp, remove the pump from clinical service and call Hospira.


 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up

Hospira, Inc., announced today a nationwide medical device correction of the GemStar Docking Station (list number 13075), used in conjunction with the GemStar infusion pump. When the docking station is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the docking station. When a GemStar Phase 3 (List 13000, 13100 or 13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used in conjunction with both a docking station and an external battery pack accessory (List 13073), there is a possibility that the GemStar pump will display error code 11/003 and give an audible alarm, indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts as measured on the external voltage input, the pump will stop the infusion. This will trigger an audible alarm and the device will display alarm code 11/003. 

If a GemStar fails to power up or the 11/003 error code stops an infusion, a delay of therapy may occur. A delay or interruption in therapy has a worst case potential to result in significant injury or death.

The GemStar Docking Station is a separately sold accessory to the GemStar infusion pump and provides an alternate power source to the GemStar pump.

Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in/of therapy could result in serious injury or death. There is no need to return the GemStar Docking Station at this time and Hospira recommends that users take the following actions:

1.To avoid a failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power up.

2.To mitigate the potential for an 11/003 error code, remove the external battery pack accessory (List 13073) from the docking station and pump prior to installing the pump into the Docking Station. If you use a docking station in conjunction with an external battery pack accessory (List 13073), this practice sould not continue. Please contact Hospira to discuss an appropriate alternative option.

Users who experience a failure to power up or an 11/003 error code should report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm CT). For additional assistance or to obtain a copy of the Urgent Medical Device Correction letter and/or a reply form, please contact Stericycle at 1-866-792-5451 (M-F, 8am-5pm ET).


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy

Includes Model No. 35700BAX and 35700ABB

Baxter has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy.

If the System 322 occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual “322” alarm). This requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.

The use of affected product may cause serious adverse health consequences, including death.

Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.

Customers who encounter a System Error 322 are instructed to:

  1. Turn the pump off by pressing the ON/OFF Key, then
  2. Turn the pump back on by pressing the ON/OFF key in order to clear the alarm.

Clinicians will need to reprogram the infusion after the pump is turned back on. If the alarm cannot be cleared using the above instructions, the device should be removed from use and sent to the facility’s biomedical engineering department. If the System Error 322 reoccurs, the pump may need to be inspected and serviced by Baxter Healthcare Corporation. Baxter Healthcare can be contacted at 1-800-356-3454 (choose option 1) Monday through Friday, 7 am to 7 pm, Eastern Time.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Flawless Beauty and Skin Products: Recall - Unapproved Drugs

Includes the following products: 

  • Roche Laroscrobine Platinum
  • Relumins Advanced Glutathione
  • QAF Pharmaceuticals Inc. Philippines Saluta Glutathione Rx
  • Tatiomax Reduced Glutathione + Hydrolyzed Collagen
  • TP Drug Laboratories Vitamin C
  • Rx Sterile Water for Injection

Flawless Beauty and Skin is voluntarily recalling eleven (11) lots of Roche Laroscrobine Platinum, Relumins Advanced Glutathione, QAF Pharmaceuticals Inc. Philippines Saluta Glutathione Rx, Tatiomax Reduced Glutathione + Hydrolyzed Collagen, TP Drug Laboratories Vitamin C, and Rx Sterile Water for Injection to the retail and consumer level. These products are currently unapproved drugs in the US.

These products claim to treat scurvy, degenerative brain and liver diseases, alcoholic liver disease, and serve as antidotes to various drugs. The label claims may result in patients not seeking proper medical treatment. Furthermore, the fact that these products may be administered intramuscularly or intravenously heightens the risk associated with unknown quality, safety, or efficacy.

The affected products were distributed in the US to wholesale, retail & Internet customers. 

Flawless Beauty and Skin is notifying its distributors and customers by sending recall letters and is arranging for return of all recalled products. Consumers, distributors & retailers that have the products which are being recalled should stop using & return to Flawless Beauty and Skin.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage

HeartWare, Inc. received reports where the driveline connector locking mechanism failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death.

The HeartWare Ventricular Assist System is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure.  Also known as HeartWare Ventricular Assist Device (HVAD), the system is designed for in-hospital and out-of-hospital settings, including transportation by fix-wing aircraft or helicopter.

Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205.
Serial Numbers: HW001 to HW 11270 and HW20001 to HW 20296.

Affected products were manufactured from March 6, 2006 through October 17, 2013 and distributed from March 17, 2006 through November 29, 2013.

Health professionals should promptly arrange a follow up visit with patients having the affected HVAD to inspect the driveline connector.

At implant and at each routine clinic visit, inspect the patient’s driveline connector for proper locking and to ensure that the connector assembly remains secure. During the inspection, pull back the protective boot and slide the locking mechanism back and forth to verify free movement of the mechanism. If the locking mechanism of the driveline connector does not move freely or fails to engage, push the connector back into the controller and immediately contact a HeartWare Clinical Engineer to perform a permanent field repair.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results

The FDA is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels.

During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels.

GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini).

Discontinue use of GenStrip Blood Glucose Test Strips. FDA recommends the use of alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients

Nano Well-being Health Inc. issued a voluntary recall of Super Arthgold, 500 mg capsules to the consumer level. FDA laboratory analysis has found the product to contain chlorzoxazone, diclofenac and indomethacin, making it an unapproved new drug.

Use of this product containing the undeclared drug ingredients has a reasonable probability of resulting in fatal adverse events in consumers and patients with underlying illnesses, including known allergy to the hidden ingredients, cardiac, gastrointestinal, hepatic, and renal conditions as well as patients who recently undergone cardiac bypass graft surgery. Consumers would be unaware that the product contains Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (and other ingredients) and may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, which include but are not limited to, myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines. The recall includes the following lots:

lot L1P1-6100/Expiration date June 25, 2016
lot L1P2-6000/Expiration date September 16, 2016

The product is used as a dietary supplement for joint pain and arthritis and is packaged in bottles of 120 capsules. The product was distributed nationwide to wholesalers.

Nano Well-being Health Inc. is notifying its distributors and customers by letter and phone call and is arranging for replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using and return to place of purchase.

Consumers with questions regarding this recall can contact Nano Well-being Health Inc. by phone at 1-714-515-4600 or e-mail address of at nanowellbeingh@gmail.com, Monday to Friday from 9:00 AM to 5 PM, Pacific Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems

Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone

FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use. 

FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks.

To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the techniques for such injections which would reduce preventable harm. The expert panel’s recommendations will be released when they are finalized. FDA will convene an Advisory Committee meeting of external experts in late 2014 to discuss the benefits and risks of epidural corticosteroid injections and to determine if further FDA actions are needed.

Patients should discuss the benefits and risks of epidural corticosteroid injections with their health care professionals, along with the benefits and risks associated with other possible treatments. See the Drug Safety Communication for a Data Summary and additional information for both patients and healthcare professionals.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution. Hospira has attributed the embedded particulate to a supplier’s glass defect.

If the particulate goes undetected and solution is administered, it could block administration of the drug to the patient, causing a delay in therapy. Other risks include local inflammation, mechanical disruption of tissue or immune response to the particulate.

Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed December 2013 through January 2014 to wholesalers/distributors, hospitals and clinics nationwide.

Hospira is working with its supplier on implementing corrective and preventive actions.

Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-877-546-7642 (M-F, 8 a.m - 5 p.m. ET).


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates

Hospira, Inc. will initiate a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10mg/mL, 30 mL single dose, Preservative - Free to the user level due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy.

If the particulate or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur.

This lot (Lot # 31-427-DK, Expiration Date 1JUL2015) was distributed nationwide to distributors/wholesalers, hospitals and clinics from September 2013 through October 2013.

Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-888-835-2723. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter

ISSUE: Cubist Pharmaceuticals, Inc. is voluntarily recalling one lot (Lot # 280453F) of CUBICIN (daptomycin for injection) 500 mg to the user level due to the presence of particulate matter, identified as glass particles.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients including: thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed Nationwide to multiple consignees.

Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot of the product and call Cubist at (855) 534-8309 to arrange for return and replacement of the affected lot.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level due to a glass defect located on the interior neck of the vial. The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.

Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue.

The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013. On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence.

Customers have been advised to check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Affected product should be returned to Stericycle, which can be contacted at 1-877-272-2158 (M-F, 8 a.m. - 5 p.m. ET).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids.

FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

It is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working

Serial numbers of units distributed in the U.S. ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031

Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may cause the system to stop working.

This defect may cause serious adverse health consequences, including hypoxemia and death. Spacelabs Healthcare received one report related to the software defect. Affected products were manufactured and distributed from March 18, 2013 through June 17, 2013. Sixteen units were distributed to hospitals in North Carolina and South Carolina.

The Spacelabs ARKON Anesthesia Delivery System is used in hospital operating rooms. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The primary users of this device are qualified physicians.

Spacelabs Field Service personnel are contacting customers affected by this recall to schedule a free software update installation that may resolve this issue. Until the software updates are installed, Spacelabs Healthcare provided the following recommendations for health care facilities with ARKON Anesthesia Delivery Systems:

  • If you continue to use your ARKON Anesthesia System, we recommend that you do NOT save spirometry loops until Spacelabs has remedied the software defect. The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.
  • Advise users NOT to use the USB ports until after your ARKON software is updated.
  • If the error does occur, the user will hear a buzzer and a warning icon will appear on the main display screen. We recommend that the user switch to emergency oxygen and manually ventilate the patient until such time as they can safely remove the system from patient use.
  • If you cycle power, the system will reboot in roughly 3 minutes and recover from the above software anomaly and mechanical ventilation can continue.

For questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate

Covidien notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device. The polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature.

Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death.

A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices are affected by this recall. The products were manufactured and distributed from May 2013 to March 2014. This issue involves both the Pipeline Embolization Device sold in the U.S., Australia, France, Germany and United Kingdom, and the Alligator Retrieval Device, which is sold in the U.S., Australia, Canada, Europe and Latin America.

The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide‐necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator Retrieval Device is intended for use in the peripheral and neuro‐vasculature for foreign body retrieval.

Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge

Power Supply Unit for Evita V500 and Babylog VN500 Ventilators

Dräger initiated a nationwide recall of the optional PS500 Power Supply
Unit used with the Evita V500 and Babylog VN500 ventilators. The device may not
indicate a low battery charge. The first indication of diminished battery capacity
may occur when the battery is totally depleted. In some cases, neither the “Battery
Low” nor the “Battery Depleted” alarm was triggered when the remaining battery
capacity fell below 10%. However, when the battery depleted totally, the power fail
alarm was generated.

Should the battery become totally depleted, mechanical ventilation will stop. Manual
ventilation will be required until the device is connected to main power.

Initial investigation revealed that the battery capacity was reduced
due to the occurrence of sulfation within the battery. Frequent short-time use of
PS500 battery power can increase sulfation, further reducing the battery capacity.
When sufficient sulfation occurs, the connection to main power cannot guarantee
fully charged batteries and the charge indicator may not reflect the currently
available battery capacity.

This recall only affects Evita V500 and Babylog VN500 ventilators equipped with the
optional PS500 power supply unit. Affected devices were distributed nationally
between June 2011 and January 2014.

As an interim solution, the batteries in the PS500 will be
replaced free of charge. Until the batteries are exchanged, Dräger recommends that
the user:

1. Use an affected device for patient transport only if absolutely necessary.

2. Not rely on the battery charge status indicator.

3. Always supervise the patient and the ventilator during transport. Ensure that a
manual resuscitator is available for manual ventilation, as recommended in the
instructions for use.

4. If the power failure alarm occurs during transport, immediately provide manual
ventilation and connect the ventilator to a wall power source to resume ventilation.

After the above mentioned battery exchange, Dräger recommends the following:

1. Minimize battery usage.

2. Avoid brief usage and charging of the PS500 (1 – 20 minutes).

3. Avoid patient transport lasting longer than 1 hour.

4. Make sure to charge the batteries for at least 24 hours.

The exchange of the existing batteries and the above recommendations are only a
temporary solution to ensure a minimum operating time of 1 hour independent from
main AC power. The permanent solution, once available, will also be provided free of
charge.

A recall notification has been sent to all current users of the recalled Evita 500
and Babylog VN500 ventilators and is available on the Dräger website at
www.draeger.com
mail&utm_source=govdelivery
Users are being contacted by a Dräger Service representative to schedule the
replacement of the PS500 batteries free of charge.

For questions regarding the operation and/or servicing of affected Dräger
ventilators in the United States, call Dräger Service Technical Support at
1-800-543-5047 (press 4 at the prompt) between the hours of 8AM to 8PM EDT Monday
through Friday.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About
Pediatric Use for Pulmonary Arterial Hypertension

FDA is clarifying its previous recommendation related to prescribing
Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH).
Revatio is FDA-approved only to treat PAH in adults, not in children; however,
health care professionals must consider whether the benefits of treatment with the
drug are likely to outweigh its potential risks for each patient.

FDA revised the Revatio drug label in August 2012, adding a warning stating that
“use of Revatio, particularly chronic use, is not recommended in children.” This
recommendation was based on an observation of increasing mortality with increasing
Revatio doses in a long-term clinical trial in pediatric patients with PAH. FDA
issued a Drug Safety Communication at that time. There may be situations in which
the benefit-risk profile of Revatio may be acceptable in individual children, for
example, when other treatment options are limited and Revatio can be used with close
monitoring.

The purpose of the August 2012 recommendation was to raise awareness
of clinical trial results showing a higher risk of mortality in pediatric patients
taking a high dose of Revatio when compared to pediatric patients taking a low dose.
This recommendation was not intended to suggest that Revatio should never be used in
children; however, some health care professionals have interpreted this information
as a contraindication, and have refused to prescribe or administer the drug.

The evidence behind FDAs initial recommendation has not changed;
this communication is clarifying the strength of the warning communicated in the
Revatio drug label.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering

GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all
alli weight loss products from U.S. and Puerto Rico retailers as the company
believes that some packages of the product were tampered with and may contain
product that is not authentic Alli.

GSK received inquiries from consumers in seven states about bottles of alli that
contained tablets and capsules that were not Alli. A range of tablets and capsules
of various shapes and colors were reported to be found inside bottles. Additionally,
some bottles inside the outer carton were missing labels and had tamper-evident
seals that were not authentic. These tampered products were purchased in retail
stores.

Alli is for weight loss in overweight adults, 18 years and older when
used along with a reduced-calorie and low fat diet. alli is a turquoise blue capsule
with a dark blue band imprinted with the text “60 Orlistat”. It is packaged in a
labeled bottle that has an inner foil seal imprinted with the words: “Sealed for
Your Protection.”

Consumers who have product they are unsure or concerned about
should not use it. Instead, they should call GSK promptly at 800-671-2554, and a
representative will provide further instructions. If they have consumed questionable
product, they should also contact their healthcare providers.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared
Penicillin

Includes Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX*

Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT,
Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug
products in liquid, tablet, capsule, ointment, and suppository forms to the consumer
level. FDA has determined that these products have the potential to contain
penicillin or derivatives of penicillin, which may be produced during the
fermentation process. In patients who are allergic to beta-lactam antibiotics, even
at low levels, exposure to penicillin can result in a range of allergic reactions
from mild rashes to severe and life-threatening anaphylactic reactions. See the
press release for a complete listing of products affected by this recall.

Pleo Homeopathic drug products are used as homeopathic drugs and have
a label stating “Distributed by SANUM USA Corp.” The affected products were
distributed nationwide through health care practitioners, who may have sold the
products through websites.

Terra-Medica is notifying its customers by letter and email and is
arranging for return of all recalled products. Consumers and distributors that have
product which is subject to the recall should stop using the products and return
them to the point of purchase. Consumers with questions regarding this recall can
contact Terra-Medica’s Customer Service Department at (888) 415-0535, ext. 1, Monday
through Friday between 8-5pm, Pacific Time Zone.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric
Shock

Playtex Manufacturing, Inc. announced a voluntary nationwide recall of
certain AC/DC power adapters that are used with the Playtex Nurser Deluxe Double
Electric Breast Pump. The casing on some adapters may become loose and separate,
resulting in a potential for electric shock.

The affected adapters were manufactured from November 2012 through July 2013. The
product can be identified by product serial number (P12324-XXXX through
P13205-XXXX). Alternatively, the product can be identified by adapter production
code (1241 through 1324). The adapters were sold along with the Playtex Nurser
Deluxe Double Electric Breast Pump. The adapters were not sold separately.

The Playtex Nurser Deluxe Double Electric Breast Pump was sold
nationwide at specialty and online retailers.

Playtex is notifying its retail partners to return any remaining
products with affected AC/DC adapters. Consumers who have purchased an affected
product should contact Playtex for a replacement by calling 1-888-207-1492 from 8
a.m. to 6 p.m. ET Monday through Friday.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products

Hospira identified that an incorrect set component was
supplied and used during the manufacturing process of the impacted product lots. The
Hemostat Dual Channel Plum Set is designed to administer blood and blood products
via the Plum infusion pump. If the Plum infusion pump is used with the affected
product, the blood product will be delivered at its intended dosage and there is no
risk of over-delivery. If the affected product is removed from the Plum infusion
pump and used in a gravity infusion, there is a risk that over-delivery may occur.
Over-delivery of blood products in the populations at greatest risk (e.g. neonates,
patients with heart and/or kidney failure, and other patients with conditions
associated with susceptibility to volume overload) may result in injuries that
require medical intervention. These injuries are expected to fully resolve with
medical intervention.

The blood sets impacted by the recall (list number 11241-03, lot
numbers 28005-5H and 34100-5H)were distributed to U.S. healthcare and veterinary
facilities from May 2013 through Dec. 2013.

Customers should check inventory and immediately quarantine any
affected product. In addition, customers should inform potential users of this
product in their organizations of this notification. Affected product should be
returned to Stericycle.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce
Mistakenly Low Blood Glucose Results

*including the OmniPod Insulin Management System with the built-in FreeStyle Blood
Glucose Meter*

Abbott is conducting a recall for the FreeStyle Blood Glucose Meter and the
FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle test
strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose
Meter may produce mistakenly low blood glucose results.

FreeStyle and FreeStyle Flash Blood Glucose Meters have not been in
production since 2010. Abbott began notifying users on Feb. 19, 2014, immediately
after the issue was discovered.

Abbott recommends the following actions for people with meters
affected by this recall:

  * Immediately contact Abbott Diabetes Care at 1-888-345-5364 to obtain a
replacement meter. 
  * If the only meter available to you is an affected meter, continue to test your
blood glucose as recommend by your doctor while you wait for your replacement
meter. When using an affected meter, follow the precautions and recommendations in
the press release.  
  * If you have access to an alternative glucose meter, immediately discontinue use
of the affected meter and take the necessary steps to continue to monitor your
blood sugar with the alternative meter. 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter

Shire Pharmaceuticals announced a voluntary recall in the United States of
one batch, packaged into three lots, of VPRIV due to the presence of visible
particulate matter, identified as stainless steel and barium sulfate. The
particulate matter was found in a small number of vials in the three packaged lots
of VPRIV. A Shire investigation identified the particulate matter root cause as the
third party supplier fill finish process.

If infused, there is a possibility of rare but serious adverse events associated
with particulate containing barium sulfate.

The following packaged lots were recalled: FEW13-001, FEW13-002, and FED13-006.
These lots were distributed nationwide to hospitals, infusion clinics, patients, and
home health agencies in the United States and all have the same NDC code
(54092-701-04) and same expiration date of 10/15 (Oct 2015).

VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme
indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult
patients with type 1 Gaucher disease. VPRIV is supplied as a sterile,
preservative-free, lyophilized powder in single-use vials, for intravenous use.

Customers should locate and remove all affected product from their
facility and/or residence. Affected product should be returned by contacting Shire
at 1-888-899-9293 (Monday through Friday between the hours of 8:00am and 5:00pm
Eastern Time). Shire has significant quantities of VPRIV to replace any affected
product. Shire does not anticipate any disruption in supply as a result of this
voluntary recall.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine
HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied
Lidocaine

Hospira, Inc. is recalling one lot ( 25-090-DK) of 1% Lidocaine HCl
Injection which is contained in the Merit Medical Systems Custom Procedural
Trays/Kits. These trays/kits were recalled due to one confirmed customer report of
visible particulate, identified in the primary product container, in the form of
dark red/black particles. The particulate was identified as oxidized stainless
steel. If oxidized stainless steel particulate is undetected, there is a potential
to be injected and/or result in delay in therapy. These effects have the potential
to result in serious life-threatening complications requiring medical intervention.

The affected products were manufactured from April 29, 2013 through August 20, 2013
and distributed from April 30, 2013 through September 20, 2013.
The presence of oxidized stainless steel particulate may potentially
put a patient at risk from a strong magnetic field exposure such as with magnetic
resonance imaging (MRI). If a metal particle in the lung becomes dislodged and
pulled through tissue, possibly causing a collapsed lung (pneumothorax) or blood in
the space between the chest wall (hemothorax), urgent and significant medical
intervention may be required. The presence of oxidized stainless steel particulate
could also result in blood clots in the lung and a stroke.

On September 30, 2013, Merit Medical sent an “URGENT PRODUCT
RECALL NOTICE” by FedEx to all its affected customers. The notice identified the
affected product, description of the problem and recommended user actions to be
taken.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Reumofan Plus: Recall UPDATE - Undeclared Drug Ingredient

[UPDATED 03/14/2014]

Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased through their
website at www.painfreebynature.com, after FDA discovered that the product was
distributed in packaging that did not reveal the presence of the active
pharmaceutical ingredients methocarbamol and diclofenac, making it an unapproved
drug. Use of this product could result in serious and life-threatening injuries.
Distribution has been completely terminated by the company.

Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone
cancer and other conditions. This product comes in thirty (30) tablet containers and
is packaged in a green and gold box. Consumers who are taking
these products or who have recently stopped taking Reumofan Plus should immediately
consult a health care professional.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization
Recommendation in Instructions Do Not Meet Sterility Assurance Requirements

Greatbatch, Inc. initiated a voluntary field corrective action for all
Standard Offset Cup Impactors after an internal review determined that the
sterilization recommendation in the Instructions for Use for the product did not
meet requirements for sterility assurance, which has the potential to result in
surgical infection. No incidents have been reported during clinical use of the
product, nor have there been any reported adverse events.

Greatbatch has developed new sterilization recommendations that meet acceptable
sterility assurance levels (AAMI ST79 standard) and provided them to affected
customers.

This action impacts all Standard Offset Cup Impactors manufactured and distributed
from 2004 to 2013. See the Press Release for a listing of affected products and part
numbers.

Greatbatch Inc. distributed Standard Offset Cup Impactors to customers
in the following countries: Australia, Austria, Belgium, China, France, Germany,
Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain,
Sweden, Switzerland, Taiwan, the United Kingdom, and the United States.

Customers who have this product should immediately begin utilizing
the new sterilization instructions. Customers with questions may contact the company
via telephone at 763-951-8235.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia
on Ventilated Patients

The FDA has concluded that Doribax (doripenem), an antibacterial drug used
to treat patients who develop pneumonia while on ventilators, carries an increased
risk of death and lower clinical cure rates compared to use of imipenem and
cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on an
FDA analysis of data from a three-year clinical trial that was prematurely stopped
in 2011 due to these safety concerns, FDA approved changes to the Doribax drug label
that describe these risks. The revised label includes a new warning about this
unapproved use. Doribax is not approved to treat any type of pneumonia.

In the clinical trial that was stopped early, patients with
ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or
10-day treatment with imipenem and cilastatin. In the intent-to-treat population,
the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than
in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also
lower in the Doribax arm.

Health care professionals should consider whether the benefits of
Doribax treatment are likely to exceed its potential risks in patients who develop
pneumonia while on ventilators. Doribax is still considered safe and effective for
its FDA-approved indications - treatment of adults with complicated intra-abdominal
infections and complicated urinary tract infections, including kidney infections
(pyelonephritis).

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall -
Contamination With Mold

Baxter International notified health professionals and their care
organizations of the recall in the United States of a single lot of DIANEAL PD-2
Peritoneal Dialysis Solution with 1.5% Dextrose 6000ml to the hospital/user level.
The recall is being initiated as a result of complaints of particulate matter,
identified as mold. The affected lot is C903799, expiration 05/15 (product code
L5B9710), NDC 00941-0411-11. Product affected by this recall was packaged in
flexible plastic containers and distributed to dialysis centers, facilities,
distributors and patients in the United States between May 2013 and January 2014.

DIANEAL is a peritoneal dialysis (PD) solution for use in chronic
renal failure patients being maintained on PD therapy.

Baxter notified customers by recall letter to instruct customers
to locate and remove any affected product from their facility. All patients who
received product from the affected lot also were contacted by recall letter and
provided instructions to arrange for product return. Dialysis centers, facilities,
distributors and patients should stop use and return to place of purchase.

As per product labeling, the container should be inspected visually for signs of
leakage prior to use. Solutions that are cloudy, discolored, contain visible
particulate matter, or show evidence of leakage should not be used.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device
Correction - Updated Labeling and Training Materials

  * HeartMate II Implant Kit with Pocket Controller: Catalog Numbers 106015 and 106016 
  * Pocket Controller: Catalog Numbers 106762 and 106017 
  * HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801 
  * Pocket Controllers that have been removed from packaging: Model Number 105109
(found on side of each unit) 

Thoratec Corporation issued a safety advisory because some patients and
caregivers have experienced difficulties with the process of changing from a primary
system controller to their backup system controller. These difficulties have
resulted in four deaths and five reports of loss of consciousness or other symptoms
of hypoperfusion. Of these nine events, eight occurred in patients who were
converted to the Pocket Controller after being originally trained on an older model,
the EPC System Controller. Two of the deaths occurred in patients who attempted to
exchange system controllers while alone and, contrary to the labeling, without
contacting the hospital first. The Urgent Medical Device Correction Letter sent to
hospitals on March 4, 2014 communicated the reported incident rate over the past
year and a half since the introduction of the Pocket System Controller in August
2012.

Thoratec’s investigations of these reports have not revealed any failures of the
devices to meet specifications or deficiencies in quality control procedures.  No
product needs to be returned to Thoratec.

The HeartMate II Pocket System Controller can be identified by the
catalog number located on the labels of the various packaging configurations.

Consumers who have the HeartMate II LVAS Pocket Controller should
immediately contact their doctor for retraining on use of the device and to receive
updated Patient Handbook information.

Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately
review the updated labeling and training materials provided in the Urgent Medical
Device Correction Letter with all clinical personnel responsible for training
patients and caregivers on the use of the Pocket System Controller. All patients
using the Pocket Controller and their caregivers should be retrained on the use of
the device and be provided with updated Patient Handbook information.

Hospitals with ongoing HeartMate II LVAS patients using the Pocket System Controller
should contact Thoratec at 1-800-528-2577 if they have any questions.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings
Reversed During Assembly

Includes the following models:

  * Giraffe Warmer with Resuscitation System 
  * Panda Warmer with Resuscitation System 
  * Giraffe Stand-Alone Infant Resuscitation System 
  * Resuscitation System Upgrade Kits 
  * Panda Freestanding with Resuscitation System 

The oxygen and air wall inlet fittings on the back panel of the
resuscitation systems were reversed during assembly. These recalled products may
interfere with oxygen delivery,  resulting in inaccurate oxygen regulation in
newborns (neonates), and may lead to low blood oxygen (hypoxia) or high blood oxygen
(hyperoxia). This may cause death in neonates, particularly those who are critically
ill. Preterm and low-birth weight babies are also at increased risk in terms of
morbidity and mortality.

The affected products were manufactured from April 1, 2007 through October 31, 2013
and distributed from October 1, 2007 through October 31, 2013. See the Recall Notice
for listing of affected lot numbers.

On November 18, 2013 GE Healthcare sent an Urgent Medical Device
Correction letter, with a return receipt, to all affected customers. The letter
identified the products, the problem, and safety instructions to be taken by the
customer along with the product correction. The firm recommends their customers
alert all potential users in their facilities about the safety notification and the
recommended actions.

The firm recommends their customers alert all potential users in
their facilities about the safety notification and the recommended actions.

For questions or concerns regarding this recall, please call the company at
1-800-345-2700, Monday – Friday, 8:00 am – 4:30 pm.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I
Recall - Potential for Coating to Flake Off

Various convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ
TCFC, item number 88241, have a potential for the coating to flake off of the wire.
Use of this recalled product may result in serious adverse health consequences.

Product codes included in this recall are 054372-1-1A, 054372-1-1B, and 054372-1-2A

An ACME Monaco Guidewire .035x150 3MMJ TCFC item number 88241 is
designed to fit inside a percutaneous catheter for the purpose of directing the
catheter through a blood vessel. This guidewire is used in various surgical
convenience kits assembled and marketed by Medline Industries, Inc. The affected
products were distributed from March 2013 through August 2013.

Customers should examine their inventory. The affected guidewires
should be removed from the kit and returned to Medline. The rest of the kit may be
used and the affected guidewire may be replaced with a sterile product from supply.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and
without Preloaded Stylet) by Teleflex Medical – Class I Recall: Potential Kinking
During Patient Use

FDA notified healthcare professionals of a Class I Recall of the Teleflex
Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. The
affected tracheal tube may kink during patient use. The affected products were
manufactured from December 2009 through November 2013 and distributed from March
2010 through December 2013. See the firm Urgent Medical Device Recall Notification
for a list of affected product codes and lot numbers.

If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing
serious patient injury including hypoxic injury and/or anoxia, and death. 

A tracheal tube is a device inserted into a patient’s windpipe
(trachea) through the nose or mouth and used to maintain an open airway. On January
6, 2014, the firm sent their customers an Urgent Medical Device Recall Notification.

Immediately discontinue use and quarantine any products with the
catalog numbers listed in the Urgent Medical Device Recall Notification. Complete
the Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer
Service. For questions about this recall, customers can call Teleflex Medical at
1-866-804-9881, 8 am to 8 pm, Eastern Time, Monday through Friday.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or
Illegible and Missing Lot Number and/or Expiry Date

Agila Specialties notified medical care organizations of a nationwide
recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL – 10 mL
and 20 mL (See the firm Press Release for a list of affected lot numbers). All of
the products bear a Pfizer label. Product was distributed Nationwide to
distributors, retailers, hospitals, pharmacies, and/or clinics.

The product was recalled due to the potential for small black particles, identified
as paper shipper labels, to be present in individual vials; the potential for
missing lot number and/or expiry date on the outer carton, and the potential for
illegible/missing lot number and expiry on individual vials. Intravenous
administration of particles may lead to impairment of microcirculation, phlebitis,
infection, embolism and subsequent infarction.

Etomidate is a hypnotic drug indicated for the induction of general
anesthesia. Etomidate 2 mg/mL is packaged in glass vials in 10 mL and 20 mL volumes.

Mylan notified its customers of the recall by letter on Feb.13,
2014. Distributors, retailers, hospitals, pharmacies, or clinics that have product
which is being recalled should stop use and discontinue distribution.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure
to Deliver Mechanical Breaths

Respironics, Inc., a Philips Healthcare business, announced a worldwide
recall of approximately 600 Philips Respironics Trilogy Ventilators due to a
potentially defective component on the Trilogy Ventilator power management board,
which could affect the function of the device. If this issue is not corrected it is
possible that the ventilator may fail to deliver mechanical breaths and that the
alarm functionality may be reduced to indicate ventilatory failure, resulting in
serious adverse health consequences or death.

The Philips Respironics Trilogy Ventilator is intended to provide
continuous or intermittent ventilatory support for the care of individuals who
require mechanical ventilation. During production testing Philips Respironics
discovered that the Trilogy ventilators contain a potentially defective ferrite
component on the power management board of the device.

This recall affects models 100, 200 and 202, shipped between December 31, 2013, and
January 30, 2014. Countries where affected devices have been shipped include the
United States, France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait,
Netherlands, and Singapore.

Customers should remove affected devices from service and to
return them to Philips for replacement. All distributors, providers, and customers
with potentially affected Trilogy devices will have their units replaced.

Philips Respironics has notified all United States and international distributors,
providers, and customers that may have devices subject to this recall, and has
provided affected device serial numbers for identification. Serial numbers of
affected devices are located on the back of the device. See product image.

Customers who have questions about the recall or require further information or
support concerning this issue, may contact their local Philips Respironics
representative via the Customer Care Center phone number: 1-800-345-6443, which is
active 24/7.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product

Ben Venue Laboratories notified health professionals and their medical care
organizations of a nationwide product recall of Acetylcysteine Solution 10%,
manufactured for Roxane Laboratories, NDC #0054-3025-02 – Lot 2005479 – Exp. Date
March 2014. The recall was initiated on February 14, 2014 after the discovery of a
single visible glass particle in a vial within the lot listed above. The nationwide
voluntary recall is to the patient level. This recall is limited to lot number
2005479.

Glass particles can cause airway obstruction resulting in symptoms of choking,
wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an
inhaled product with glass particles has the potential to cause choking which could
be life-threatening. Aerosolization of small glass particles in the airways could
result in recurrent infections (due to obstruction of airways, and decreased
clearance of airway secretions).

Acetylcysteine is indicated as adjuvant therapy for patients with
abnormal, viscid, or inspissated mucous secretion. It is usually delivered via a
Nebulizer, but can also be delivered via direct instillation into a tracheostomy, or
into the bronchial-pulmonary tree during bronchoscopy.

Hospitals, emergency rooms, clinics, physician offices and other
healthcare facilities and providers should not use the product lot listed above for
patient care and should immediately quarantine any product for return. Patients who
may have received product dispensed from this one lot should return the product to
their pharmacist. Distributors/retailers that have not received a recall packet
should contact GENCO Pharmaceutical Services, 6101 North 64th Street, Milwaukee, WI
53218.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

L-citrulline by Medisca: UPDATE -  Additional Lot Numbers Recalled

*UPDATE 02/15/2014.* FDA alerts health care professionals and patients that Medisca
is voluntarily recalling certain lots of its L-citrulline product after testing
indicated that it does not contain any L-citrulline

  * Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B,
95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain
L-citrulline. Pharmacists should see updated FDA Statement below for more product
details. 
  * Medisca is voluntarily recalling all L-citrulline product with the above lot
numbers. 
  * Health care professionals should discontinue dispensing from these lots, contact
patients, and return all unused product to Medisca Inc. 
  * Patients and caregivers should stop using any product with these lot numbers. 
  * FDA has received several adverse event reports associated with Medisca’s
L-citrulline product. FDA is investigating reports that may include additional lot
numbers, continues to investigate the full scope of this issue and will continue
to provide additional information as it becomes available. 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

L-citrulline by Medisca: Alert - Potentially Subpotent Product

FDA is notifiying health care professionals, patients, and caregivers of
adverse events reported in patients who were administered L-citrulline repackaged
and distributed by Medisca Inc. L-citrulline is used to treat certain urea cycle
disorders, rare genetic disorders primarily diagnosed in children. FDA has received
adverse event reports associated with potentially subpotent L-citrulline. Subpotent
L-citrulline in patients with certain urea cycle defects can lead to high ammonia
levels, which is serious and potentially life-threatening.

In addition to the identified lot number 96453, FDA is investigating reports that
may include additional lot numbers.

Medisca supplies pharmacies nationwide with L-citrulline. The product
is sold to pharmacies and clinics in containers filled with powdered L-citrulline,
and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain
a powder.

FDA recommends health care professionals quarantine lots of
L-citrulline from Medisca and not administer to patients until FDA provides
additional information.

Patients should contact their physician or health care provider if they have
concerns about the use of L-citrulline.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA
to Review Heart Failure Risk

FDA has requested clinical trial data from the manufacturer of saxagliptin
to investigate a possible association between use of the type 2 diabetes drug and
heart failure. FDAs request resulted from a study  published in the New England
Journal of Medicine (NEJM), which reported an increased rate of hospitalization for
heart failure, when the heart does not pump blood well enough, with use of
saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive
treatment. The study did not find increased rates of death or other major
cardiovascular risks, including heart attack or stroke, in patients who received
saxagliptin. The manufacturer is expected to submit the trial data to FDA by early
March 2014, after which FDA will conduct a thorough analysis and report findings
publicly.

At this time, FDA considers information from the NEJM study to be preliminary.
Analysis of the saxagliptin clinical trial data is part of a broader evaluation of
all type 2 diabetes drug therapies and cardiovascular risk.

Saxagliptin is used along with diet and exercise to lower blood sugar
in adults with type 2 diabetes. It works by increasing the amount of insulin
produced by the body after meals, when blood sugar is high.

Patients should not stop taking saxagliptin and should speak with
their health care professionals about any questions or concerns. Health care
professionals should continue to follow the prescribing recommendations in the drug
labels.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial
Contamination

FDA notified healthcare professionals to follow up with patients who
received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz.,
between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial
contamination in lot #778961 of Rx Formulations’ calcium gluconate injection
product. The testing identified gram-positive rod bacteria in the product. A
contaminated injectable drug can put patients at risk of adverse health consequences
and possibly a serious infection.

Rx Formulations recalled products marketed as sterile on December 13, 2013.

Health care providers and hospital staff should immediately check
their medical supplies, and quarantine the affected products.

Patients who were administered any drug marketed as sterile produced by Rx
Formulations between Nov. 7 and Dec. 11, 2013, and who have concerns, should contact
their health care provider.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Testosterone Products: Drug Safety Communication - FDA Investigating Risk of
Cardiovascular Events

FDA is investigating the risk of stroke, heart attack, and death in men
taking FDA-approved testosterone products. We have been monitoring this risk and
decided to reassess this safety issue based on the recent publication of two
separate studies that each suggested an increased risk of cardiovascular events
among groups of men prescribed testosterone therapy. FDA is providing this alert
while it continues to evaluate the information from these studies and other
available data. FDA will communicate final conclusions and recommendations when the
evaluation is complete.

Testosterone is a hormone essential to the development of male growth
and masculine characteristics. Testosterone products are FDA-approved only for use
in men who lack or have low testosterone levels in conjunction with an associated
medical condition.

At this time, FDA has not concluded that FDA-approved testosterone
treatment increases the risk of stroke, heart attack, or death. Patients should not
stop taking prescribed testosterone products without first discussing any questions
or concerns with their health care professionals. Health care professionals should
consider whether the benefits of FDA-approved testosterone treatment is likely to
exceed the potential risks of treatment. The prescribing information in the drug
labels of FDA-approved testosterone products should be followed.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions
For Use

Codman Neuro is informing physicians of this incorrect statement and
updating the product's Instructions For Use (IFU). The product's IFU incorrectly
noted: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close
to the nidus at high flow rates where venous opacification occurs on contrast
injections within 1/2 second."  The use of incorrectly mixed product can result in
the liquid mixture solidifying too slowly in unintended areas, which may lead to
embolization or reflux into arteries and pulmonary vessels. This could result in
significant impact to the patient, including neurological deficits, pulmonary emboli
and possibly death.

The correct information should have stated: "A 2:1 (67% Ethiodized Oil / 33% nBCA)
for Intranidal injections without AV fistulae or high flow rates in order to more
deeply penetrate the nidus."

Trufill n-BCA is indicated for embolization of cerebral arteriovenous
malformations (AVMs) when presurgical devascularization is desired.  In October
2013, Codman Neuro identified an incorrect statement in the product's IFU that
described suggested mixing ratios for use in certain treatment conditions.

Product is not being removed from the market. Trufill nBCA products associated with
the correction notice were manufactured between February 25, 2010 and October, 31,
2013, distributed to hospitals and surgical centers, and include the following
product codes (all lots): 631400 (Two 1 gram tubes nBCA) and 631500 (One 1 gram tube
nBCA).

All customers who have purchased Trufill nBCA are reminded to
review the correction notice and other product literature to ensure proper mixing
procedures are followed. They may also call Codman Neuro with questions or to report
any malfunction or adverse event on weekdays between the hours of 7:00am and 6:30pm
Eastern Time at 1-866-491-0974, Option 2.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

StemAlive 90 Capsules: Recall - Contains Undeclared Milk

Stemvida, of Ontario California, has recalled StemAlive 90 Capsules, found
to contain undeclared milk. People who have an allergy or severe sensitivity to milk
(bovine colostrum) run the risk of serious or life-threatening allergic reaction if
they consume this product. StemAlive was distributed in Arizona, California,
Colorado, Florida, New Jersey, New York, Nevada, Oklahoma, Texas and Utah.

The product is in a white plastic bottle with white lid, the brand is
StemVida International with a white and gold label. The lot numbers and expiration
dates are 8419 (Exp.05/2015 and 06/2015), 8486 (Exp.07/2015), 8535 (Exp. 08/2015),
8598 (Exp. 10/2015), 8652 (Exp. 12/2015), 8863 (Exp. 01/2016 and 02/2016), 8872
(Exp. 03/2016), 8873 (Exp. 04/2016 and 05/2016), 9040 (Exp. 08/2016 and 09/2016),
9258 (Exp. 10/2016) and 9314 (Exp. 11/2016). The lot number and expiration date is
printed in black ink at the bottom of the label.

Consumers who have purchased StemAlive 90 Capsules are urged to
return it to the company for replacement or refund. Consumers with questions may
contact the company at 888-950-8432 between the hours of 9:00am and 8:30pm PST.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review

The Mentholatum Company announced a voluntary recall of Rohto Arctic, Rohto
Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops. The recall was initiated
due to a manufacturing review at the production facility in Vietnam involving
sterility controls. To date, there has been no evidence indicating that product does
not meet specifications.

The products are sold nationwide over-the-counter at pharmacies and
retail stores. This recall includes only lots of product that were manufactured in
Vietnam. This recall affects Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and
Rohto Cool eye drops that were made in Vietnam only, which can be identified by the
words "Made in Vietnam" on the side carton panel under the company name and address
information, as well as on the back label of the bottle. The lot numbers for
products made in Vietnam will include the letter "V," for example, "Lot 3E1V," and
will be located on the bottom panel of the carton, and on the bottom of the eye drop
bottle.

The Mentholatum Company is notifying its distributors and
retailers by letter to stop distribution and follow instructions in the recall
letter. Consumers that have recalled product should contact the company for
instructions. Questions about this recall may be directed to The Mentholatum Company
Customer Service Department at 1-877-636-2677 Monday – Friday 9 AM to 5 PM (EST).

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA
Statement - Recommendation to Discontinue Prescribing and Dispensing

FDA is recommending health care professionals discontinue prescribing and
dispensing prescription combination drug products that contain more than 325
milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are
no available data to show that taking more than 325 mg of acetaminophen per dosage
unit provides additional benefit that outweighs the added risks for liver injury.
Further, limiting the amount of acetaminophen per dosage unit will reduce the risk
of severe liver injury from inadvertent acetaminophen overdose, which can lead to
liver failure, liver transplant, and death. 
 
Cases of severe liver injury with acetaminophen have occurred in patients who:

• took more than the prescribed dose of an acetaminophen-containing product in a
24-hour period; 
• took more than one acetaminophen-containing product at the same time; or 
• drank alcohol while taking acetaminophen products.

In January 2011 FDA asked manufacturers of prescription combination
drug products containing acetaminophen to limit the amount of acetaminophen to no
more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this
action to protect consumers from the risk of severe liver damage which can result
from taking too much acetaminophen. This category of prescription drugs combines
acetaminophen with another ingredient intended to treat pain (most often an opioid),
and these products are commonly prescribed to consumers for pain, such as pain from
acute injuries, post-operative pain, or pain following dental procedures.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever
medication, and is often combined with other ingredients, such as cough and cold
ingredients. FDA will address OTC acetaminophen products in another regulatory
action. Many consumers are often unaware that many products (both prescription and
OTC) contain acetaminophen, making it easy to accidentally take too much.

More than half of manufacturers have voluntarily complied with the FDA request.
However, some prescription combination drug products containing more than 325 mg of
acetaminophen per dosage unit remain available. In the near future FDA intends to
institute proceedings to withdraw approval of prescription combination drug products
containing more than 325 mg of acetaminophen per dosage unit that remain on the
market.

FDA recommends that health care providers consider prescribing
combination drug products that contain 325 mg or less of acetaminophen. FDA also
recommends that when a pharmacist receives a prescription for a combination product
with more than 325 mg of acetaminophen per dosage unit that they contact the
prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or
two capsule dose may still be prescribed, if appropriate. In that case, the total
dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When
making individual dosing determinations, health care providers should always
consider the amounts of both the acetaminophen and the opioid components in the
prescription combination drug product.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge
Leak

Tandem Diabetes Care announced that it is initiating a voluntary recall of
specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The
affected cartridges may be at risk for leaking. A cartridge leak could potentially
result in the device delivering too much or too little insulin, which can lead to a
serious adverse event. 

Affected lots were shipped on or after December 17, 2013. The affected
lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

Customers should discontinue using cartridges labeled with the
affected lots.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem

FDA notified healthcare professionals of a Class I recall of the Covidien,
Puritan Bennett 840 Series Ventilator. Due to a software problem, a diagnostic code
(XB0069) may be triggered. This causes the ventilator to stop functioning,
triggering the safety alarm and causing the patient to suddenly be required to
breathe on his or her own.  This product may cause serious adverse health
consequences, including death.

These devices are used on critically ill patients who may not be able
to continue breathing without the ventilator. The affected Software Part Number is
4-070212-85, Revision AB-AG, Manufactured: April 30, 1998 to March 12, 2010 and
Distributed: August 1, 2008 to October 31, 2010.

On December 16, 2013, Covidien sent its customers an Urgent
Medical Device Voluntary Field Correction letter to all affected customers. The
letter identified the product, the problem, and the action to be taken by the
customer. Customers were instructed to continue using their Puritan Bennett 840
ventilators until they are able to install the software update outlined in the
letter.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible
Harm From Exceeding Recommended Dose

Marketed under the brand-name Fleet, and as store brands and generic products. 

FDA is warning that using more than one dose in 24 hours of
over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare
but serious harm to the kidneys and heart, and even death. 

FDA has become aware of reports of severe dehydration and changes in the levels of
serum electrolytes from taking more than the recommended dose of OTC sodium
phosphate products, resulting in serious adverse effects on organs, such as the
kidneys and heart, and in some cases resulting in death. These serum electrolytes
include calcium, sodium, and phosphate. According to the reports, most cases of
serious harm occurred with a single dose of sodium phosphate that was larger than
recommended or with more than one dose in a day.
OTC sodium phosphate drug products include oral solutions taken by
mouth and enemas used rectally. Marketed under the brand-name Fleet, and as store
brands and generic products. Available as single-ingredient drug products,
containing either sodium biphosphate or sodium phosphate, and as combination drug
products containing both ingredients.

Consumers and health care professionals should always read the
Drug Facts label for OTC sodium phosphate drugs and use these products as
recommended on the label, and not exceed the labeled dose.  Caregivers should not
give the oral products to children 5 years and younger without first discussing with
a health care professional.  Health care professionals should use caution when
recommending an oral dose of these products for children 5 years and younger.  The
rectal form of these products should never be given to children younger than 2
years.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall -
Incorrect Factory-set Measure

Nipro Diagnostics initiated a voluntary recall and replacement of a limited
number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed both in the
United States and outside the United States.

The company determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose
Meters have an incorrect factory-set unit of measure that displays the glucose
result in mmoi/L rather than mg/dl. If a consumer were not to notice the incorrect
unit of measure, it is possible that the meter result could be read as a lower than
expected blood glucose result.

There are 501 affected TRUEbalance meters and 105 affected TRUEtrack
meters that were distributed in the United States from September 2008 to May 2013.
The company is sending notifications to pharmacies, durable medical equipment
providers, mail order companies and distributors where the TRUEbalance and TRUEtrack
meters are recommended or sold in the United States.

Consumers who have a TRUEbalance or TRUEtrack meter should:

Check to confirm if they have an affected TRUEbalance or TRUEtrack meter by
obtaining the serial number from the serial number label on the back of the meter
and visiting www.NiproDiagnostics.com

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure
to Bacteria or Virus

including SafeSpout, SafeShower HH (Hand Held), and SafeShower FH (Fixed Head) *

The Nephros non-medical water filtration SafeSpout and SafeShower products
may pose risks to health potentially resulting in adverse health events or death.
Exposure to harmful bacteria may occur when the fiber filter or the sealing
compound, holding the fiber in place, breaks apart. If the filter breaks, patients
could be exposed to bacteria or viruses, which could result in infection or death.
To date, reports of one death and one infection are associated with this recall.

This recall involves all production lots of the following point-of-use (POU)
filters, manufactured between July 2011 and September 2013 and distributed between
October 2011 and October 2013:

SafeSpout 70-0233, 70-0238 
SafeShower HH (Hand Held) 70-0237
SafeShower FH (Fixed Head) 70-0236

The Nephros SafeSpout and SafeShower are intended to filter water for
washing and drinking. They are intended to be installed at the end of a standard
sink faucet or shower head.

If you are in possession of any of the filters identified above,
please remove them from use immediately.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products

Baxter International and FDA notified health professionals and their
medical care organizations of a voluntary recall in the United States of two lots of
CLINIMIX and one lot of CLINIMIX E Injection parenteral nutrition products due to
complaints of particulate matter found in the products. The affected product codes
are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot
P28512, exp 05/14). The affected lots were distributed to customers between May 2012
and October 2013.

If infused, particulate matter may result in blockages of blood vessels, which can
result in stroke, heart attack, or damage to other organs such as the kidney or
liver. There is also the possibility of allergic reactions, local irritation, and
inflammation in tissues and organs.

CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid
with Electrolytes in Dextrose with Calcium) Injections are premixed sterile
intravenous (IV) parenteral nutrition products that come in multi-chambered
containers and are used as a caloric component and as a protein source in a
parenteral nutrition program.

Baxter has notified customers, who have been directed not to use
product from the recalled lots and to locate and remove all affected product from
their facility.

According to the product labeling, parenteral drug products should be inspected
visually for particulate matter and discoloration whenever solution and container
permit. The use of a final filter is recommended during administration of all
parenteral solutions where possible.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of
Anesthetic Gases, Ventilation and Oxygenation*

Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary
field corrective action of the disposable Multi Absorber Original after becoming
aware of a potential safety issue due to air leakage associated with the CO2 Multi
Absorber.  The Multi Absorber Original may have a thin wall condition which may lead
to small holes in the water (drain tube). This may result in a loss of anesthetic
gases, ventilation and oxygenation.

The voluntary corrective action was issued after receiving customer
complaints and product returns; upon further inspection the returned absorbers were
found to leak due to a hole in the drain tube. The affected product number is
M1173310 containing lot numbers 12001 through 13031. Not affected are products with
lot numbers 13032 and higher.

Vital Signs is following up with all customers and will replace
all affected units at no cost to customers. For additional information regarding
this corrective action, please contact Customer Service (domestic) at 800-345-2700
(option 2 followed by option 2) if you have any questions or concerns. You may also
contact International Customer Service at +1-800-932-0760 (option 2). Hours of
Operation: Monday to Friday from 8:00 am EST to 5:00 pm EST.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection,
USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution

Product NameProduct CodeNDCContainer SizeLot #Exp. 5% Dextrose Injection, USP 2B0089
0338-0017-38 100 mL P285288 Nov-13 0.9% Sodium Chloride Injection, USP 2B1308
0338-0049-31 50 mL P297283 Aug-14 0.9% Sodium Chloride Injection, USP 2B1302
0338-0049-18 100 mL P292326 Apr-14 P293993 May-14 0.9% Sodium Chloride
Injection, USP 2B1309 0338-0049-38 100 mL P293514 Apr-14 

Baxter International Inc. initiated a voluntary recall to the hospital/user
level of one lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride
Injection, USP due to particulate matter found in the solutions.

Injecting a product containing particulate matter may result in blockages of blood
vessels, which can result in stroke, heart attack or damage to other organs such as
the kidney or liver. There is also the possibility of allergic reactions, local
irritation and inflammation in tissues and organs.

Dextrose Injection, USP is an intravenously administered injectable
indicated as a source of water and calories. Sodium Chloride Injection, USP is an
intravenously administered injectable indicated as a source of water and
electrolytes and for use as a priming solution in hemodialysis procedures. These 50
mL and 100 mL containers are primarily used for admixture of medication and as
priming solutions. Products affected by this recall were packaged in flexible
plastic containers with 96 containers per carton.

Affected product was distributed to healthcare centers and distributors in Saudi
Arabia, Singapore, United Arab Emirates, and the United States and Puerto Rico. The
affected lots were distributed to customers between May 2012 and October 2013.

Baxter has notified customers, who are being directed not to use
product from the recalled lots. Customers that have product affected by this recall
should stop use and arrange for return. Unaffected lot numbers can continue to be
used according to the instructions for use. Affected product should be returned to
Baxter for credit by contacting Baxter Healthcare Center for Service at
1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m.,
Central Time. Unaffected lots of product are available for replacement.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate
Matter

Hospira initiated a voluntary nationwide recall to the user level for one
lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05),
Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange
particulate on the inner surface and floating in the solution.

If particulate goes undetected and solution is administered, the particle may
potentially block the infusion of the solution to the patient, resulting in a delay
in therapy. If smaller pieces of the particulate break off and become free floating
within the solution, they may pass through the catheter into the patient, resulting
in local inflammation or mechanical disruption of tissue. Chronically, following
sequestration, local granuloma formulation is possible. In consideration of the
reddish orange color of the particulate, if there is iron within the particle that
is infused, it may put a patient at risk when undergoing MRI (strong magnetic field
exposure), as the particle could potentially be dislodged and be pulled through
tissue, causing local inflammation and tissue trauma.

The recalled lot was distributed to distributors/wholesalers,
hospitals, and pharmacies located in AL, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD,
MA, MI, MS, MO, NV, NJ, NC, OH, OK, PA, TN, TX, UT, VA, WA, and WI between September
2013 through October 2013. Lidocaine is packaged 10 units per carton/180 units per
case in single dose glass fliptop vials.

Anyone with an existing inventory should immediately stop use and
quarantine any affected product and return the product to Stericycle. Hospira will
be notifying its direct distributors/customers via a recall letter and will arrange
for impacted product to be returned to Stericycle for returns processing. For
additional assistance, call Stericycle at 1-855-695-8596 between 8 a.m. and 5 p.m.,
ET, Monday through Friday.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared
Ingredients

The FDA is advising consumers to immediately stop using a product called
Mass Destruction, marketed as a dietary supplement for muscle growth. The product is
labeled to contain at least one synthetic anabolic steroid and has been linked to at
least one reported serious illness. The product’s ingredients are undergoing further
analysis by the FDA. Liver injury is generally known to be a possible outcome of
using products that contain anabolic steroids and steroid-like substances. In
general, anabolic steroids may cause other serious long-term consequences in women,
men and children. These include adverse effects on blood lipid levels; increased
risk of heart attack and stroke; masculinization of women; shrinkage of the
testicles; breast enlargement; infertility in males; and short stature in children. 

The FDA was alerted by the North Carolina Department of Health and
Human Services of a serious injury associated with use of Mass Destruction. The
report described a previously healthy 28-year-old male with liver failure requiring
transplant after several weeks of product use. Mass Destruction is manufactured for
Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on
the Internet. An investigation is underway to identify the product’s manufacturer.

Consumers who suspect they are experiencing problems associated
with Mass Destruction or other body building products should consult a health care
professional, especially if they have experienced unexplained fatigue, abdominal or
back pain, discolored urine, or any other unexplained changes in their health.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance

Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of
sterile products dispensed nationwide due to concerns of lack of sterility
assurance. All unexpired lots of sterile compounded products are subject to the
recall. Sterile products are injectable medications, IVs, eye drops, pellet
implants, nasal sprays, inhalation solutions, and eye ointments.

The recall was issued after a single, isolated report of an adverse event involving
a patient in California who received a compounded medication from the pharmacy. Out
of an abundance of caution, Abrams Royal is voluntarily recalling all sterile
products within expiry. If there is microbial contamination in products intended to
be sterile, patients are at risk for serious, potentially life-threatening
infections.

All recalled products have a label that includes Abrams Royal Pharmacy’s name and
phone as well as a lot number. While not every label contains an expiration date,
consumers can call the pharmacy with the lot number and find out the expiration
date.

The recalled products were distributed to health care facilities,
physicians, and patients from June 17, 2013, through December 17, 2013.

Abrams Royal Pharmacy is notifying its customers by mail and is
arranging for the return of all recalled medication. To return product or request
assistance related to this recall, users should contact Abrams Royal at
214-349-8000, Monday through Friday, between 9:00 a.m. and 5:00 p.m. CST.

Customers that have product which is being recalled should stop using it and contact
the pharmacy to arrange for return of unused product.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting
Erections

Including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER,
Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR

FDA is warning that methylphenidate products, one type of stimulant drug
used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances
cause prolonged and sometimes painful erections known as priapism. Based on a recent
review of methylphenidate products, FDA updated drug labels and patient Medication
Guides to include information about the rare but serious risk of priapism. If not
treated right away, priapism can lead to permanent damage to the penis.

Priapism can occur in males of any age and happens when blood in the penis becomes
trapped, leading to an abnormally long-lasting and sometimes painful
erection. Another ADHD drug, Strattera (atomoxetine), has also been associated with
priapism in children, teens, and adults.

Priapism appears to be more common in patients taking atomoxetine than in those
taking methylphenidate products; however, because of limitations in available
information, FDA does not know how often priapism occurs in patients taking either
type of product.

See the FDA Drug Safety Communication for additional information, including a Data
Summary.

Methylphenidate products are central nervous system (CNS) stimulants
used to treat attention deficit hyperactivity disorder (ADHD).

Healthcare professionals should talk to male patients and their
caregivers to make sure they know the signs and symptoms of priapism and stress the
need for immediate medical treatment should it occur. Younger males, especially
those who have not yet reached puberty, may not recognize the problem or may be
embarrassed to tell anyone if it occurs.

Encourage your patients to read the Medication Guide they receive with every filled
prescription. Use caution when considering switching patients from methylphenidate
to atomoxetine. Patients should not stop taking a methylphenidate product without
first discussing it with your health care professional.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion:
Recall - Visible Particles

Alexion Pharmaceuticals, Inc. is providing information regarding a
previously communicated voluntary recall of two lots of Soliris (eculizumab)
Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two
lots were found to contain visible particles. At that time, Alexion provided
instructions to return any unused vials of Soliris from these two lots at the
distributor level. Alexion is now providing the same instructions at the
hospital/user level.

The administration of particulate, if present in a parenteral drug, poses a
potential safety risk to patients in two general areas: immunogenicity and
thromboembolic events. Particulates could cause blockage of flow of blood in
vessels, which could be life-threatening. To date, there have been no product
complaints of particulates, or identifiable safety concerns attributed to the
product consumed from the affected lots. As previously stated, Alexion does not
anticipate any interruption to patient supply of Soliris.

The product is approved as a treatment for patients with paroxysmal
nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two ultra-rare
disorders. Alexion and its distributors typically ship Soliris to healthcare
providers in small quantities, which are timed to individual patient infusions, with
the product being consumed before more is shipped. As product was last shipped on
Nov. 1, 2013, Alexion believes there is little, if any, inventory currently being
held at the hospital or user level.  Soliris (eculizumab) 300 mg/30 mL Concentrated
solution for intravenous infusion only NDC 25682-001-01, Lot number: 10010A and
10001-1.

Any person in possession of vials of Soliris from these lots
should stop use and arrange for return of the product to Alexion immediately by
calling 1-888-SOLIRIS (888-765-4747). 

Alexion will replace any recalled vials of Soliris. Unaffected lot numbers can
continue to be used according to the instructions for use. Healthcare professionals
and pharmacists with questions regarding this recall can contact Alexion at
1-888-765-4747.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety
Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To
Deliver Appropriate Shock

FDA issues safety communication on HeartStart automated external
defibrillators from Philips Healthcare. Certain HeartStart automated external
defibrillator (AED) devices made by Philips Medical Systems, a division of Philips
Healthcare, may be unable to deliver needed defibrillator shock in a cardiac
emergency situation.  These devices were manufactured and distributed between 2005
and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1
OnSite.

An AED is a device that automatically analyzes the heart rhythm in
victims of sudden cardiac arrest and delivers an electrical shock to restore its
normal rhythm. AEDs help save lives of cardiac arrest victims when they are working
properly and used correctly.

In September 2012, Philips Healthcare initiated the recall of HeartStart FRx,
HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an
internal electrical component. The recall affected approximately 700,000 devices. In
a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers
with updated information about the failure of an internal electrical component that
could cause the AEDs to fail to deliver a shock.

In March 2013, the FDA issued a proposed order that if finalized would require
manufacturers of AEDs and accessories to submit premarket approval applications
that focus specifically on the critical requirements necessary to assure AEDs are
safe and effective. The main objective of this proposed regulatory approach is to
improve the reliability of AEDs so that they can continue to save lives.

All owners of the Philips HeartStart AEDs should contact Philips
Healthcare immediately at 1-800-263-3342, and select option 5 for technical
support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm
Pacific Time. All owners should keep the recalled HeartStart AED in service until
Philips Healthcare replaces the device or you can obtain another working AED. If
unsure if Philips HeartStart AED is affected by this recall or you received a
replacement unit after the September 2012 recall notification, please contact
Philips Healthcare for additional information. Please be aware that the Philips
HeartStart AEDs are designed to automatically test themselves at regular intervals
to ensure they are ready for use. The HeartStart AED should emit a triple chirp
sound and have a flashing “i-button” if it detects a serious problem that could
prevent the HeartStart AED from delivering an electrical shock.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions

FDA is warning the public that the anti-seizure drug Onfi (clobazam) can
cause rare but serious skin reactions that can result in permanent harm and death.
FDA approved changes to the Onfi drug label and the patient Medication Guide to
describe the risk of these serious skin reactions.   

These skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN), can occur at any time during Onfi treatment. However, the
likelihood of skin reactions is greater during the first 8 weeks of treatment or
when Onfi is stopped and then re-started. All cases of SJS and TEN in the FDA case
series have resulted in hospitalization, one case resulted in blindness, and one
case resulted in death.
Onfi is a benzodiazepine medication used in combination with other
medicines to treat seizures associated with a severe form of epilepsy called
Lennox-Gastaut Syndrome.

Patients should be closely monitored for signs or symptoms of
SJS/TEN, especially during the first 8 weeks of treatment or when re-introducing
therapy. Health care professionals should discontinue use of Onfi and consider an
alternate therapy at the first sign of rash, unless it is clearly not drug-related.

Patients taking Onfi should seek immediate medical treatment if they develop a rash,
blistering or peeling of the skin, sores in the mouth, or hives. Patients should not
stop taking Onfi without first talking to their health care professionals. Stopping
Onfi suddenly can cause serious withdrawal problems, such as seizures that will not
stop, hallucinations, shaking, nervousness, and stomach or muscle cramps.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall -
Erroneously Low Blood Glucose Results

Abbott is initiating a voluntary recall of 20 lots of FreeStyle and
FreeStyle Lite Blood Glucose Test Strips in the United States. These lots of test
strips may produce erroneously low blood glucose results when used with both
"FreeStyle Blood Glucose Meter" and "FreeStyle Flash Blood Glucose Meter” [neither
of which have been in production since 2010], as well as the OmniPod Insulin
Management System.
When the test strips are used with the newer FreeStyle brand meters including
FreeStyle Freedom Blood Glucose Meter, FreeStyle Lite Blood Glucose Meter and
FreeStyle Freedom Lite Blood Glucose Meter, the blood glucose test results are not
affected. Testing with the FreeStyle InsuLinx Blood Glucose Meter is not affected by
this action, as FreeStyle InsuLinx Blood Glucose Meter uses FreeStyle InsuLinx test
strips.

The affected test strips are from lots that hold expiration dates from
between May 2014 and March 2015.
The company is notifying healthcare professionals, pharmacies,
distributors and customers about the recall; customers affected by this action are
instructed to call Abbott's diabetes care customer service at 1-888- 736-9869 for a
replacement of the affected test strips at no charge.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter

Risk Managers, Critical Care Medicine, Cardiology

Baxter International Inc has initiated a voluntary recall of one lot of
Nitroglycerin in 5% Dextrose Injection due to particulate matter found in one vial.
If infused, particulate matter could lead to potential venous and/or arterial
thromboembolism (blockage of blood vessels). Other adverse events associated with
injection of particulate matter include inflammation due to foreign material,
particularly in the lungs, and local irritation of blood vessels. 

Nitroglycerin in 5% Dextrose Injection (Intravenous) is indicated for
treatment of peri-operative hypertension (treatment of high blood pressure before,
during and after surgery); for control of congestive heart failure in the setting of
acute myocardial infarction (during a new onset heart attack, a weakness of the
heart muscle may cause fluid to build up in the lungs and other body tissues); for
treatment of angina pectoris (chest pain) in patients who have not responded to
sublingual nitroglycerin and ß-blockers (beta blocker drugs); and for induction of
intraoperative hypotension (low blood pressure during surgery).

Baxter’s Nitroglycerin in 5% Dextrose Injection is packaged in 250 mL glass
containers, with 12 glass containers per carton. The affected product code is
1A0694, and the affected lot number is G105197. Product affected by this recall was
distributed to healthcare centers and distributors in Colombia, Saudi Arabia and the
United States.

Customers should locate and remove all affected product from their
facility. The affected lot was distributed to customers between January 17, 2013,
and October 10, 2013. Unaffected lot numbers can continue to be used according to
the instructions for use. Affected product should be returned to Baxter for credit
by contacting Baxter Healthcare Center for Service at 1-888-229-0001 between the
hours of 7:00 a.m. and 6:00 p.m., Central Time.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits:
Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail

FDA notified healthcare professionals of a Class I Recall due to a
potential defect in the CAS I/II Absorber products employed in the BleaseSirius
Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part
Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may
fail due to loose fastening hardware in an absorber.

In the worst case, this would result in a large leak from the absorber circuit while
operating in bag mode and could impede the ability to provide ventilation in bag
mode. Operation in vent mode along with all monitoring and alarm functions will
continue to operate normally.

The affected products may cause serious adverse health consequences, including death.

These products are used in the hospital environment and in locations
not requiring mobility of the products. They provide respiratory support to deliver
oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing
circuits with or without the use of a mechanical ventilator, and may be used to
deliver anesthetic vapor.

On Nov. 1, 2013, Spacelabs Healthcare sent an Urgent Medical
Device Correction letter to all affected customers. Spacelabs Healthcare also sent a
customer letter (translated as necessary) to all international subsidiaries and
distributors of record by e-mail on Nov. 6, 2013. 
Customers were instructed to immediately advise their staff of the problem.

Customers with questions were instructed to contact Spacelabs Healthcare at
1-800-522-7025 and select 2 for Technical Support.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System
Deficiencies And Lack Of Premarket Approval (PMR)

CLR Medicals International Inc., initiated a nationwide recall of Viscocel
and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the
Quality System regulations for Medical Device Manufacturers. No injuries have been
reported to date for the Viscocel and Viscocel Plus products, however, multiple
cases of endopthalmitis were reported in 2011 for the firm’s Visco Supreme, a
similar product manufactured at the firm under the same conditions.

Recalled Viscoelastic products were manufactured from September, 2011 through
September 19, 2013 and distributed from October 2011 through November 2013.  This
recall includes all lots of Viscocel and Viscocel Plus, manufactured from September
01, 2011 to September 19, 2013.

The Viscoelastic products, intended for human and animal use, have
been determined to be a public health concern due to distribution in the US without
FDA approval, which evaluates the safety and efficacy of the product, and violations
of the QSR regulations related to sterility, and biocompatibility that may result in
the release of contaminated products. 

This recall is being conducted in accordance with the labeled
shelf life of the product and any expired product should be discarded. CLR Medicals
International Inc. is notifying its domestic distributors by direct mail, email or
telephone and is arranging for the return of recalled Viscoelastic products. For
more information, health professionals and consumers should contact CLR Medicals
International Inc. between the hours of 9AM – 6PM Pacific Time, Monday - Friday.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift

The proximal and distal pressure sensor calibration can drift resulting in
the pump failing the Proximal or Distal Occlusion Operational Test or resulting in
an error being reported during device setup or infusion.
A pump with this issue may, instead of reporting an error, not detect occlusions or
issue false occlusion alarms, which will stop the infusion and invoke visual and
audible warnings to the user. This issue may also result in the pump shutting down.

Potential risks include a delay/interruption in therapy or over-infusion, which have
a worst case potential to result in significant injury or death.

The GemStar Infusion System is a small, lightweight, single-channeled
device designed for use in the home, hospital or anywhere electronic infusion is
required. The device is intended for use in intravenous, arterial, subcutaneous,
short-term epidural infusion and parenteral administration of general I.V. fluids,
medications, nutritional foods and blood/blood products.

All GemStar Infusion Pumps (Models 13000, 13100, 13150, 13086, 13087, 13088) that
were either manufactured or had a pressure sensor replaced during servicing of the
pump since January 1, 2009 could be affected.

Immediately perform proximal and distal occlusion tests as defined
in the GemStar Technical Service Manual. If the device fails either of the tests,
remove it from clinical service. Contact Hospira at 1-800-441-4100 (Monday - Friday,
8:00 AM - 5:00 PM Central Standard Time) to report the issue and arrange for the
return of the device for recalibration. Add the performance of a proximal and distal
occlusion test to your yearly GemStar maintenance schedule.

Healthcare professionals are advised to weigh the risk/benefit to patients
associated with the use of the device when administering critical therapies.
Customers should consider the use of an alternative pump, particularly in patients
in which a delay or interruption in therapy or an over-infusion could result in
significant injury or death.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of
Some Prescribing and Dispensing Restrictions
including Avandia, Avandamet, Avandaryl, and generics

FDA has determined that recent data for rosiglitazone-containing drugs,
such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk
of heart attack compared to the standard type 2 diabetes medicines metformin and
sulfonylurea. As a result, FDA is requiring removal of the prescribing and
dispensing restrictions for rosiglitazone medicines that were put in place in 2010.
This decision is based on FDA review of data from a large, long-term clinical trial
and is supported by a comprehensive, outside, expert re-evaluation of the data
conducted by the Duke Clinical Research Institute (DCRI).

Previous data from a large, combined analysis of mostly short-term, randomized
clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so
FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the
Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of
rosiglitazone medicines to help ensure that their benefits outweighed the risks.

Although some scientific uncertainty about the cardiovascular safety of
rosiglitazone medicines still remains, in light of the new re-evaluation of the
Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in
Diabetes (RECORD) trial, FDAs concern is substantially reduced and the rosiglitazone
REMS program requirements will be modified. FDA is also requiring revisions to the
rosiglitazone prescribing information and the patient Medication Guide to include
this new information.

Refer to the Drug Safety Communication for more details.

Rosiglitazone is a treatment option that can improve blood sugar
control in some patients with type 2 diabetes.

Patients with type 2 diabetes should continue to work closely with
their health care professionals to determine treatment options that are most
appropriate. Health care professionals, pharmacies, and patients will no longer be
required to enroll in the rosiglitazone REMS program to be able to prescribe,
dispense, or receive rosiglitazone medicines. As part of the REMS, sponsors will
ensure that health care professionals who are likely to prescribe rosiglitazone
medicines are provided training based on the current state of knowledge concerning
the cardiovascular risk of rosiglitazone medicines. Manufacturers will also send
Dear Healthcare Provider and Dear Professional Society letters to educate
prescribers about the new information.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates

"including Auto-Injectors for"

Atropen (atropine)
DuoDote (atropine/pralidoxime chloride)
morphine sulfate
pralidoxime chloride
diazepam

FDA is aware of a disruption in supply to health care providers and
emergency response personnel of Atropen (atropine), DuoDote (atropine/pralidoxime
chloride), morphine sulfate, pralidoxime chloride, and diazepam auto-injectors
manufactured by Meridian Medical Technologies, a Pfizer Inc. company. FDA and
Meridian are working together to resolve the disruption as quickly as possible, but
it is unclear how long this disruption may persist.

FDA concluded that it was scientifically supported that certain lots of DuoDote can
be used for an additional year beyond the manufacturer’s original labeled expiration
date. FDA is continuing to assess whether these identified lots of DuoDote can
receive further expiration date extensions if needed, and whether additional lots of
DuoDote that were not listed in FDA’s September 5, 2013, memo can have their
expiration date extended.

FDA is currently reviewing data for the potential use of Atropen (atropine), DuoDote
(atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride, and
diazepam auto-injectors beyond their labeled expiration dates in order to mitigate
any potential shortages of these medically necessary drugs.

FDA will provide additional information about use of these
products beyond the labeled expiration date in the coming weeks. Until FDA provides
additional information, these expired auto-injectors may be used for patient care
under emergency situations when no other product is available.

Health care providers and emergency response personnel who have any of the
auto-injectors manufactured by Meridian identified above that are nearing or beyond
the labeled expiration date should retain the products until FDA is able to provide
additional information regarding the continued use of these products.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare
but Serious Risk of Heart Attack and Death

The FDA is warning health care professionals of the rare but serious risk
of heart attack and death with use of the cardiac nuclear stress test agents
Lexiscan (regadenoson) and Adenoscan (adenosine). FDA has approved changes to the
drug labels to reflect these serious events and updated recommendations for use of
these agents. At this time, data limitations prevent FDA from determining if there
is a difference in risk of heart attack or death between Lexiscan and Adenoscan.

The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously
contained information about the possible risk of heart attack and death with use of
these drugs. However, recent reports of serious adverse events in the FDA Adverse
Event Reporting System (FAERS) database and the medical literature prompted approval
changes to the drug labels to include updated recommendations for use.

Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear
stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help
identify coronary artery disease. They do this by dilating the arteries of the heart
and increasing blood flow to help identify blocks or obstructions in the heart’s
arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the
healthier, unblocked or unobstructed arteries, which can reduce blood flow in the
obstructed artery. In some cases, this reduced blood flow can lead to a heart
attack, which can be fatal.
 
Screen all nuclear stress test candidates for their suitability
to receive Lexiscan or Adenoscan. Avoid using these drugs in patients with signs or
symptoms of unstable angina or cardiovascular instability, as these patients may be
at greater risk for serious cardiovascular adverse reactions. Cardiac resuscitation
equipment and trained staff should be available before administering Lexiscan or
Adenoscan.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack
of Sterility Assurance

Nature's Pharmacy and Compounding Center of Asheville, NC is voluntarily
recalling all lots of sterile products compounded by the pharmacy that are not
expired to the consumer level. The product will be in the form of an injectable drug
or an eye drop. The recall is being initiated due to concerns associated with
quality control procedures that present a potential risk to sterility assurance that
were observed during a recent FDA inspection.

This recall is being conducted as a result of an inspection conducted
by the North Carolina Board of Pharmacy. These products were supplied to the
offices of licensed medical professionals and to patients by prescription within the
pharmacy's local market area in North Carolina. They were distributed from January
1, 2013 to present. Out of abundance of caution and in the interest of the
pharmacy's patients, Nature's Pharmacy has decided to voluntarily proceed with this
recall process and to cease production of all sterile products.

Medical professionals, clinics, or patients who have these
products should stop its use and return them to the place of purchase. Clinics
should contact any patient that has received treatment using any of these sterile
products. Consumers or health care providers with questions regarding this recall
may contact Nature's Pharmacy at 828-251-0094 or toll free at 800-645-8201 Monday
through Friday, 9:30 am to 6:00 pm EST.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medtronic Guidewires: Recall - Potential For Coating On Surface To Delaminate And Detach

Medtronic, Inc. announced that FDA has classified the company's recently
initiated voluntary field action related to certain guidewire. Based on an internal
investigation following a limited number of complaints, including one patient
injury, Medtronic began notifying hospitals and distributors worldwide the week of
Oct. 21 that some models of its guidewires from recent lots have the potential for
the coating on their surface to delaminate and detach. The notification requested
that all potentially affected units be quarantined immediately and returned to the
company as soon as possible for credit and replacement.

The guidewires covered by this recall are designed to facilitate
percutaneous coronary interventions or the placement of left ventricular leads for
cardiac rhythm devices. They include specific lots from the following eight
product lines that were manufactured after mid-April 2013:


  * Cougar nitinol workhorse guidewire 
  * Cougar steerable guidewire 
  * Zinger stainless steel workhorse guidewire 
  * Zinger steerable guidewire 
  * Thunder extra-support guidewire 
  * Thunder steerable guidewire 
  * ProVia crossing guidewire 
  * Attain Hybrid guide wire 

Additional information about the recall, including the lot numbers
of affected product, is accessible through the Medtronic website.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA
Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection*

The U.S. Food and Drug Administration (FDA) is requesting label and
packaging changes to enhance the safe use of certain over-the-counter (OTC) topical
antiseptic products. This request is the result of our ongoing evaluation of
infrequent but continuing reports of infections resulting from antiseptic products
labeled for preoperative or preinjection skin preparation.  When used properly,
topical antiseptics are safe and effective products to reduce the number of bacteria
on patients’ skin prior to surgery or injections.  However, most often,
contamination of topical antiseptics occurs when organisms are introduced into the
product by users.  Therefore, health care professionals and patients should follow
all label directions to decrease the chances of infection.
Outbreaks associated with the use of contaminated topical antiseptics have been
reported in the medical literature and to the Centers for Disease Control and
Prevention (CDC). Clinical infections have also been reported to FDA, leading to
some product recalls.  The reported outcomes ranged from localized infections at
injection sites to systemic infections that resulted in death.  FDA has reviewed
reports of four deaths, five cases of wound infection, seven cases of peritonitis,
10 cases of septic arthritis, 14 cases of indwelling catheters requiring
replacement, 16 cases of injection site infection, and 32 cases of bacteremia. 
These infections have been confirmed to be caused by contaminated antiseptic
products.  Affected products included all commonly used antiseptic ingredients,
including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium
products.  Organisms implicated in the outbreaks included Bacillus cereus,
Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia
pickettii, Serratia marcescens, and Mycobacterium abscessus.

Over-the-counter (OTC) topical antiseptic drugs for use according to
the label instructions to reduce the number of bacteria on the skin prior to surgery
or injections. When used properly, over-the-counter (OTC) topical antiseptics are
safe and effective products to reduce the number of bacteria on the skin prior to
surgery or an injection.  Commonly used products contain isopropyl or ethyl alcohol,
povidone iodine, poloxamer iodine, benzalkonium chloride, benzethonium chloride, or
chlorhexidine gluconate as a single agent or in combination with alcohol. These
products are marketed as solutions, swabs, pads saturated with a solution, and
applicators containing a solution. Currently available as both single-use and
multiple-use products.  Topical antiseptics are not required to be manufactured as
sterile and so may become contaminated with bacteria during manufacturing. Labeling
stating a product is sterile means it was treated with a process during
manufacturing to eliminate all potential microorganisms. However, even topical
antiseptics manufactured with a sterile process, can become contaminated if proper
care is not taken when using them.  The term nonsterile on the product label means
it was not sterilized during manufacturing; it does not mean the product contains
harmful bacteria.

To further reduce the risk of infection with improper topical
antiseptic use and the possibility of these products becoming contaminated with
bacteria during use, we are requesting that manufacturers package antiseptics
indicated for preoperative or preinjection skin preparation in single-use
containers. 

  * To reduce the risk of infection, ensure the products are used according to the
directions on the label.  
  * The antiseptics in these single-use containers should be applied only one time
to one patient.  

  * We also recommend that health care professionals and patients do not dilute
antiseptic products after opening them.  

  * Applicators and any unused solution should be discarded after the single
application. 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

OxyElite Pro Dietary Supplements by USP Labs: Recall - Products Linked to Liver
Illnesses

The U.S. Food and Drug Administration announced today that USPlabs LLC, of
Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that
the company markets. The company took this action after receiving a letter from the
FDA stating that the products have been linked to liver illnesses and that there is
a reasonable probability that the products are adulterated.  
In a review of 46 medical records submitted to the FDA by the Hawaii Department of
Health, the records indicated that 27 patients, or 58 percent, had taken a dietary
supplement labeled as OxyElite Pro prior to  becoming ill. Seventeen of the 27
patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement
they were taking. One death has occurred among these patients, another patient has
required a liver transplant, and others await liver transplants. For a list of
products affected please see the FDA News Release.

By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings
indicating a link between the use of OxyElite Pro products and a number of liver
illnesses reported in Hawaii. The FDA also noted that cases of liver damage after
use of these OxyElite Pro products had been found in a number of other states.
In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the
company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed
to be adulterated. The products contained aegeline, a new dietary ingredient (i.e.,
an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a
history of use or other evidence of safety. The letter stated that failure to
immediately cease distribution of all dietary supplements containing aegeline may
result in enforcement action.
In addition to the products being recalled, the FDA continues to advise consumers
not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath
Could Remove Particulate 

FDA notified healthcare professionals of the Class 1 recall of TorFlex
Transseptal Guiding Sheath Kit.  The sheath could remove particulate of less than 5
mm from the dilator. The particulate could potentially migrate into a patient’s
bloodstream.  

The TorFlex Transseptal Guiding Sheath Kit is a single use device
designed for safe and easy catheterization and angiography of specific heart
chambers and locations. The components of the device include a sheath, a dilator and
a J-tipped guidewire.  On Sept. 23, 2013 Baylis Medical Company sent an “URGENT DEVICE RECALL”
letter to their customers. This recall covers 1,035 kits manufactured between 12/22/2011 and
07/24/2013. See list of affected lot numbers in Recall Notice.

Customers were instructed to examine their inventory and
quarantine affected TorFlex Transseptal Guiding Sheath lots. Customers are then
asked to sign and return a Medical Device Correction Acknowledgment Form directly to
Baylis to their Fax number (905) 602-5671.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to
Decrease Risk of Spinal Column Bleeding and Paralysis*

The U.S. Food and Drug Administration (FDA) is recommending that health
care professionals carefully consider the timing of spinal catheter placement and
removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing
of anticoagulant medications for some time interval after catheter removal to
decrease the risk of spinal column bleeding and subsequent paralysis after spinal
injections, including epidural procedures and lumbar punctures. These new timing
recommendations, which can decrease the risk of epidural or spinal hematoma, will be
added to the labels of anticoagulant drugs known as low molecular weight heparins,
including Lovenox and generic enoxaparin products and similar products.

Epidural or spinal hematomas are a known risk of enoxaparin in the
setting of spinal procedures and are already described in the Boxed Warning and the
Warnings and Precautions sections of the labels for Lovenox and generic enoxaparin
products. However, these serious adverse events continue to occur (see Data
Summary). To address this safety concern, FDA worked with the manufacturer of
Lovenox, Sanofi-Aventis, to further evaluate this risk and to update the Warnings
and Precautions section of the Lovenox label with these additional timing
recommendations. The labels for generic enoxaparin products will also be revised
accordingly, as will those of other low molecular weight heparin-type products. 
It is important to note that all anticoagulants carry the risk of causing spinal
bleeding when used in conjunction with epidural/spinal anesthesia or spinal
puncture. We are continuing to evaluate the safety of other anticoagulants to
determine if additional label changes are needed.

Health care professionals and institutions involved in performing
spinal/epidural anesthesia or spinal punctures should determine, as part of a
preprocedure checklist, whether a patient is receiving anticoagulants and identify
the appropriate timing of enoxaparin dosing in relation to catheter placement or
removal. To reduce the potential risk of bleeding, consider both the dose and the
elimination half-life of the anticoagulant:

For enoxaparin, placement or removal of a spinal catheter should be delayed
for at least 12 hours after administration of prophylactic doses such as those
used for prevention of deep vein thrombosis. Longer delays (24 hours) are
appropriate to consider for patients receiving higher therapeutic doses of
enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily). 

A post procedure dose of enoxaparin should usually be given no sooner than 4
hours after catheter removal. 

In all cases, a benefit-risk assessment should consider both the risk for
thrombosis and the risk for bleeding in the context of the procedure and patient
risk factors. 


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall - Deformed
Cannula Tip

FDA notified healthcare professionals that Edwards Lifesciences LLC issued
a Class I Recall of the EMBOL-X Glide Protection System. The tip of the catheter is
being recalled due to a deformed cannula tip. When force is applied to the tip
during insertion or removal, it may lead to a separation and embolize. Use of this
recalled product may cause serious adverse health consequences, including death.

This recall includes model numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD,
EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Edwards Lifesciences is recalling all lot numbers of the EMBOL-X Glide Protection
System Cannulae that have not expired.

The EMBOL-X access device system can help capture material such as
blood clots or tissue fragments during short-term (equal to or less than 6 hours)
cardiopulmonary bypass surgery when surgeons may need to introduce and remove
devices into the vascular system.

On Sept. 16, 2013 the firm sent their customers an Urgent Field
Safety Notice, with instructions for quarantine and return of the affected products.
Call Edwards Customer Service at 800-424-3278 from 6:00 AM – 4:30 PM Pacific
Standard Time or contact your Edwards sales representative concerning this recall.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with
Co-packaged Oral Syringe

The Perrigo Company announced that it has initiated a voluntary, nationwide
product recall to the retail level of 18 batches of its acetaminophen infant
suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a
box under store brand products including Babies R Us, Care One and more.
The recall is being initiated because of the remote potential that a small number of
packages might contain an oral dosing syringe without dose markings. Using an oral
syringe without dose markings can result in inaccurate dosing, especially in infants
who could mistakenly get too high a dose.

This over the counter product is indicated for the relief of fever
and minor aches and pains and can be used in infants, children and adults. These
recalled products are sold by distributors nationwide and distributed through retail
stores.

If the oral dosing device contained in the package has dose
markings (for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL), no action is required, and the
consumer can continue to use the product consistent with the label instructions. If
the package contains an oral dosing device that does not have dose markings, the
consumer should not use the product and should call Perrigo’s Consumer Affairs
Department, toll free, 1-800-719-9260. Consumers should contact their physician or
healthcare provider if they have any questions, or if they or their children
experience any problem that could possibly be related to this drug product.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class
1 Recall - Drug Over Infusion

FDA and Codman & Shurtleff, Inc. notified healthcare professionals of the
class 1 recall of MedStream Programmable Pump and MedStream Refill Kit due to air in
the pump reservoir which may release a higher dosage of drug than expected, leading
to drug overdose. This product may cause serious adverse health consequences,
including low blood pressure (hypotension), an abnormally slow heart rate
(bradycardia), loss of consciousness, and/or death.

The MedStream Programmable Infusion Pump is an implanted drug delivery
system used in the US for the chronic delivery of Baclofen to treat muscle symptoms
and used in Europe, Middle East, and Africa (EMEA) for the chronic delivery of
Morphine or Baclofen.  Refill kits are used in filling and re-filling of the
MedStream pump reservoir. On August 13, 2013, Codman & Shurtleff, Inc. sent a
Medical Device Field Safety Notice Letter to US and International customers. The
affected products were manufactured from March 2009 to September 2012 and
distributed from January 08, 2010 to July 19, 2013. Please refer to Class 1 Recall
Notice for Product Codes and link to Letter.

Contact Codman Representative or Codman Neuro Clinical Support at
1-800-660- 2660 for questions about the recall. Report any malfunctions or adverse
events related to the MedStream Programmable Infusion Pumps and refill kits to
1-866-491-0974 (choose option 2).

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile
Products: Recall - Particulate Matter Found in Vials

Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots
of certain unexpired human and veterinary sterile products to the consumer level due
to particulate matter found in vials of a compounded dextrose injection product
dispensed to a local hospital. Further testing and analysis of the medication is
being conducted. If there is microbial contamination in products intended to be
sterile, patients are at risk for serious, potentially life-threatening infections.

The recalled products were distributed to hospitals and consumers
located only within Michigan from July 1, 2013, through October 19, 2013.  No
products were distributed out of state.  Refer to the Firm Press Release for a
detailed list of affected products.

Customers that have product which is being recalled should stop
using it and contact the pharmacy to arrange for return of unused product. Customers
with questions regarding this recall may contact the pharmacy at 248-446-2643,
Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT. Consumers should contact
their physician or health care provider if they have experienced any problems that
may be related to taking or using these products.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy

FDA notified health professionals and medical care organizations of a class
1 recall of this product due to deployment issues that range from failure to deploy,
partial deployment, and difficult deployment. This product may cause serious adverse
health consequences, including possible complications of bleeding, loss of limb,
heart attack (myocardial infarction), stroke, vascular surgery, and/or death.

The LifeStent Solo Vascular Stent is an implantable self-expanding
stent and delivery system used to improve the inner open space of a blood vessel
(luminal diameter) in the treatment of lesions caused by the abnormal narrowing in a
blood vessel (symptomatic de-novo or restenotic lesions). The affected products were
manufactured and distributed from November 2011 to June 13, 2012. To locate product
codes and lot numbers of affected products, refer to FDA’s Class I Recall
information under “Additional Links”.

On September 30, 2013, Bard Peripheral Vascular sent an “Urgent:
Medical Device Recall Notification” letter informing affected customers of the
product, problem, and actions to be taken. Customers were instructed to (1) Complete
the Recall and Effectiveness Check Form (even if you no longer have the recalled
product) and fax form to Bard Peripheral Vascular at 1-800-994-6772, and (2) Call
Bard Peripheral Vascular’s Recall Coordinator to receive a Return Authorization
Number or Consignment Recall Number.

Bard Peripheral Vascular Inc. can be contacted at 1-800-321-4254 (Option #2,
Extension 2727) Monday through Friday, 7 am to 4 pm MST.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals):
Recall - Aseptic Processing Simulation Results

Nephron Pharmaceuticals initiated a voluntary recall, at the retail level,
of ten lots of product due to results from an internal monitoring process. NPC
performs aseptic process simulation as part of an internal processes to assure
product quality. All of the lots listed above met and passed NPC’s quality
specifications at the time of manufacture. In accordance with published guidance
regarding aseptic processing simulation from the FDA, NPC has initiated this recall
as a precautionary measure.

The affected product is identified as Albuterol Sulfate Inhalation
Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25) and
lots A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and
A3A42A

NPC is asking retailers to remove the affected lots from store
shelves and is asking consumers to discontinue use and dispose of any product they
may have that is included in this recall.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication - Reports of
Tissue Erosion

FDA is alerting health care providers and patients that in very rare
instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in
life-threatening emergencies that require immediate surgery. According to published
estimates, these events occur in approximately 1 to 3 of every 1,000 patients
implanted with the Amplatzer ASO. As of March 31, 2013, there have been 234,103
Amplatzer ASO devices sold worldwide.

The device rubbing against the wall of the heart can erode the tissue and create a
hole. It can also lead to further scraping or erosion through tissue in the upper
chambers (atria) of the heart, primarily in the top of the atria near the aorta.
This scraping may also cause separate or simultaneous holes in the aortic root,
potentially leading to blood building up in the sac surrounding the heart (cardiac
tamponade). If too much blood builds up in this sac, the heart will not be able to
work properly.

The St. Jude Amplatzer Atrial Septal Occluder is a cardiac implant
device used in children and adults to treat an abnormal hole between the upper left
and right chambers (atria) of the heart, known as an atrial septal defect (ASD). The
metal device is put into place through a thin tube (catheter) inserted into a vein.
This is considered a minimally invasive method for ASD closure, and is an
alternative to open heart surgery.

Between 2002 and 2011, the FDA received more than 100 reports of erosions associated
with the St. Jude Amplatzer ASO. During the same period, several medical journals
contained articles reporting tissue erosion among patients implanted with this
device.

To better understand how erosion impacts the performance of the Amplatzer ASO and
assess potential risk factors related to the occurrence of erosion, the FDA is
requiring St. Jude to conduct a study of patients who have been recently implanted
with the device. The study is designed to estimate the incidence of erosion events
within seven days, one month, six months, and 12 months after the implantation of
the Amplatzer ASO.

Healthcare professionals should review the updated Instructions
For Use (IFU) for the Amplatzer ASO before implanting the device. Consider the
potential for erosion when talking to patients about long- and short-term benefits
and risks of treatment options, including implantation with the Amplatzer ASO.
Educate patients implanted with the Amplatzer ASO to seek immediate medical
attention if they develop symptoms such as chest pain, numbness, sudden weakness,
dizziness, fainting, shortness of breath, or rapid heartbeat.

The FDA does not recommend device removal for patients who have the Amplatzer ASO
unless physicians determine it is appropriate for their particular patient(s). The
risks associated with device removal surgery may be equal to or greater than the
risk of erosion. See the FDA Device Safety Communication for additional information
and recommendations.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary
Field Corrective Action - Potential Safety Issue

GE Healthcare has initiated a voluntary field corrective action due to a
potential safety issue that involves unresponsive buttons on the display of
the Engström ventilator and Aespire View, Aisys, and Avance anesthesia machines. 
Due to a manufacturing issue the buttons on the left, right, and bottom keypads may
not always detect a user’s button presses. This may result in the inability to
access certain menu functions which could possibly lead to delay in treatment. To
date, no patient injuries have been reported with regards to this issue.

The affected units were manufactured between the dates of April 23,
2013 and July 22, 2013.

Clinicians may continue to use their Engström ventilator and
Aespire View, Aisys, and Avance anesthesia machines, but should be aware of this
potential safety issue. GE Healthcare has begun notifying customers with affected
units through an Urgent Medical Device Correction letter, which alerts users of the
concern and provides instructions to mitigate the issue.  The instructions explain
that to mitigate this issue, the user may notice that a button press may not actuate
the desired function. Usually by pressing the key again, the device will respond as
expected; if a button has no response, the menu function may be accessible through
the use of the control wheel. The instructions direct that if none of the above
steps can be performed, discontinue use and contact a GE Healthcare Service
Representative. GE Healthcare is following up with all customers and will correct
all affected systems at no cost to customers. For additional information regarding
this field action, please contact GE Healthcare’s Customer Service line (24 hours a
day, 7 days a week) at 1-800-345-2700.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field
Corrective Action - Potential Safety Issue

GE Healthcare has initiated a voluntary field corrective  for the Avance,
Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or
10.00 (Avance CS2) software due to a potential safety issue. Clinicians may
continue to use their Avance, Aisys and Avance CS2 anesthesia delivery system, but
should be aware that a unique sequence of  inputs and a collapsed bellow could
result in delivery of higher-than-expected tidal volume when using the Pressure
Control Ventilation – Volume Guarantee (PCV-VG) mode. All safety over-pressure
controls and alarms will continue to function properly, however, over delivery of
tidal volume this may result in alterations to blood flow within the thorax that,
under extreme circumstances, may result in gradual reductions in blood pressure. To
date, no patient injuries have been reported with regards to this issue.

The affected units were manufactured from February 2011 through July
2013. The unique sequence of inputs includes transitioning from mechanical PCV-VG
mode to manual ventilation, changing the set tidal volume (while in manual mode),
and then returning to mechanical PCV-VG mode. 

To avoid this situation, when using PCV-VG mode, clinicians are
advised not to adjust the ventilator tidal volume while in a manual ventilation
mode. At any time during the use of the device, should an over delivery of tidal
volume occur while in PCV-VG mode, transitioning to a different ventilation mode
will resolve the issue. GE Healthcare has begun notifying customers with affected
units through an Urgent Medical Device Correction letter, which alerts users of the
concern and provides instructions to mitigate the issue. GE Healthcare is following
up with all customers and will correct all affected systems at no cost to customers.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.:
Recall - Visible Particulate Matter*

B. Braun Medical Inc. is voluntarily recalling one lot of 1g Cefepime for
Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) to the
consumer level. The 1g Cefepime for Injection USP and Dextrose Injection USP lot
has been found to contain visible organic particulate matter in a reserve sample
unit. Visible particulate matter, including metals, and organic material such as
cotton fibers or hair, may illicit inflammatory responses, both chronic and acute,
and may be life threatening (e.g. systemic inflammatory response syndrome (SIRS and
/ or anaphylaxis). If a right to left cardiac shunt is present, the particulate may
lead to arterial emboli and result in stroke, myocardial infarction,
respiratory failure, and loss of renal and hepatic function or tissue necrosis.
Other adverse effects associated with intravenous injection of particulate matter
include foreign body granulomata, particularly in the lungs, and local irritation of
blood vessels. B.Braun has not received any reports of adverse events related to
this lot to date.

The product is used as a cephalosporin antibacterial indicated in the
treatment of infections caused by susceptible strains of designated microorganisms.
The product is packaged in a Duplex single dose intravenous, plastic container with
24 units per case. The affected lot H3A744, which expires January 2015, was
distributed nationwide to licensed distributors, hospitals and pharmacies, and
distributed to customers between the dates of February 4, 2013 and March 1, 2013

Patients reporting any problems that may be related to the use of
this product should be advised to contact a physician and report all issues to
B.Braun at 1-800-854-6851. B.Braun is notifying its distributors and customers by
written, return receipt letters and is arranging for return of all recalled product.
Distributors and customers that have inventory of the 1g Cefepime for Injection USP
and Dextrose Injection USP of lot H3A744 should discontinue use immediately and
contact  B.Braun’s Customer Support Department at 1-800-227-2862, Monday through
Friday, 8 a.m. to 7 p.m. EST for instructions for returning the affected product and
to arrange for replacement product.

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July 27, 2011 Pat Farnack's conversation with Jerry Butler who has Addison's Disease about the long road to diagnosis and his creation of the website to help those with Addison's. listen MP3

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