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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease

FDA is warning health professionals of the risks associated with the regarding use of dietary supplements containing live bacteria or yeast in immunocompromised persons. A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. Rhizopus oryzae mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder, which is formulated to contain three species of live bacteria.

FDA, along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health, are investigating the death of this preterm infant who developed gastrointestinal mucormycosis.  In mid-November, Solgar issued a recall for certain lots of ABC Dophilus Powder and public health warnings were issued advising customers and consumers not to use the recalled product.

FDA is informing healthcare providers that dietary supplements, including those that are formulated to contain live bacteria or yeast, are generally not regulated as drugs by the FDA.  As such, these products are not subject to FDA’s premarket review or approval requirements for safety and effectiveness, nor to the agency’s rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.

FDA is warning health professionals of the potential risks associated with the use of dietary supplements containing live bacteria or yeast in immunocompromised persons. Gastrointestinal mucormycosis primarily occurs in immunocompromised persons, such as prematurely born infants.

FDA advises practitioners to approach the application of these interventions with caution. FDA encourages health care providers who use dietary supplements containing live bacteria or yeast as drugs (e.g., to treat, mitigate, cure, or prevent a disease or condition) to submit an Investigational New Drug Application (IND) for FDA review


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alere INRatio2 PT/INR Professional Test Strips: UPDATE - Significant Discrepancy in INR Results May Lead To a Delay In An Urgent Medical Decision

UPDATE 12/09/2014.  Alere Inc. initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed.

The INRatio and INRatio2 PT/INR Monitor system should not be used on patients with any of the following conditions:

  • Anemia of any type with hematocrit less than 30%
  • Any conditions associated with elevated fibrinogen levels including:
    • Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
    • Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
    • Severe infection (e.g., sepsis)
    • Chronically elevated fibrinogen for any reason
    • Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
  • Any bleeding or unusual bruising, clinically observed or reported by the patient

Patients with any of the conditions listed above should immediately be transitioned to a laboratory INR method for monitoring their INR and warfarin therapy. 


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units

Heart Sync Inc. notified customers of a Voluntary Urgent Device Correction for certain Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units.

These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the AED must be used. This may result in a delay in electrical therapy, which can lead to death or serious adverse consequences.

The affected multi-function electrodes were distributed globally to distributors and medical facilities from October 26, 2011 through November 26, 2014. There are a total of 113,750 electrodes affected by this voluntary device correction.

No product needs to be returned to Heart Sync. Heart Sync alerted customers to this issue by letter on November 11, 2014 and is in the process of revising its labeling to clarify the use of these electrodes as incompatible with the Philips FR3 and FRx AED units. 


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination

UPDATED 12/02/2014. Recall Classified as Class I. Since Philips Healthcare’s May 2014 recall, the firm has received 12 new complaints of visible mold on their devices, including one injury.

[Posted 11/14/2014]

Children’s Medical Ventures, a Philips Healthcare business, announced today a recall of all Gel-E Donut gel pillow and Squishon 2 gel cushion products due to potential mold contamination of the products.

In May 2014, Children’s Medical Ventures initiated a recall due to mold contamination of some products, which occurred during the manufacturing process. The mold types detected on the products have been identified as types which are commonly found in indoor and outdoor environments. There is potential for the mold to be transferred to patient environments once the outer pack is opened. There is the possibility of fungal infection should patients come in contact with the mold, which could be superficial or invasive and life threatening.

The Children’s Medical Ventures Gel-E Donut gel pillow and Squishon 2 gel cushions are intended to help support an infant’s head or body in a hospital environment. The products are intended to be used in Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU), and neonatal care centers.

Refer to the firm press release for a listing of recalled model numbers and quantities.

Customers are being asked to discontinue use and dispose of all Gel-E Donut gel pillow and Squishon 2 gel cushion products in their facility, even if mold is not visible. Customers who have questions about the recall or require further information or support concerning this issue, may contact their local Philips representative at (770) 510-4681 or (770) 510-4684.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results

Including Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1

Incorrect test results may occur for the following antibiotics: Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. The test may report certain bacteria as sensitive to one of these antibiotics when the bacteria are actually resistant. Using these recalled devices may cause ineffective patient treatment, and in rare instances may contribute to death.

These devices can identify certain gram negative bacteria and measure how these bacteria (Enterobacteriaceae, Acinetobacter species and Pseudomonas aeruginosa) respond to antibiotics such as Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone in the laboratory. The results can help health care providers select the correct antibiotic treatment for a patient.

On October 17, 2014 and again on November 7, 2014 the firm sent Urgent Medical Device Recall letters to their customers stating the problem and the steps to be taken. Customers who have these recalled devices in their inventory should stop using the recalled devices, discard any remaining products in inventory, complete and return the Field Correction Effectiveness Check that is attached to the Urgent Medical Device Recall letter, and forward the Urgent Medical Device Recall letters to others who may have received the recalled devices.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units

CONMED Corporation notified customers of a Voluntary Urgent Device Correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the incompatibility issue until the AED must be used. This may result in a delay in therapy.

The affected multi-function electrodes were distributed globally to distributors and medical facilities from March 1, 2012 through October 29, 2014.

No product needs to be returned to CONMED. CONMED alerted customers to this issue by letter on November 6, 2014 and is in the process of revising its labeling to clarify the use of these electrodes as incompatible with the Philips FR3 and FRx AED units.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported

FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label.

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems.

Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS), a brain and spinal cord disease in which patients experience multiple episodes of weakness, numbness, and other nervous system signs and symptoms that partially or completely resolve overs weeks or months. Patients may develop persistent symptoms and disability over time.

Healthcare professionals should:

  • Tell patients taking Tecfidera to contact you if they develop any symptoms that may be suggestive of progressive multifocal leukoencephalopathy (PML). Symptoms of PML are diverse, progress over days to weeks, and include the following: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation, leading to confusion and personality changes. The progression of deficits can lead to severe disability or death.
  • Stop Tecfidera immediately at the first sign or symptom suggestive of PML and perform an appropriate diagnostic evaluation.
  • Monitor lymphocyte counts in Tecfidera-treated patients according to approved labeling.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.

Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.

Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. Product was distributed through Northstar label to retail outlets nationwide.

Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase. Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


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

UPDATED 11/24/2014. FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications.

The boxed warning informs health care providers and patients that:

  • Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

The two contraindications advise of the following:

  • Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
  • Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch

Baxter International Inc. voluntarily recalled one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL.

The inability to detect this overpouch mislabeling at the point of care may result in the administration of a dose lower than intended. In the high-risk patient population – patients prone to severe electrolyte imbalance – this hazardous situation may lead to serious, life-threatening adverse health consequences. There have been no reported adverse events associated with this issue to date.

Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Products were distributed to customers in the U.S. between June 23, 2014 and October 2, 2014.

Baxter has notified customers, who are being directed not to use product from the recalled lot. Recalled 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 lot numbers can continue to be used according to the instructions for use. Unaffected lots of product are available for replacement. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Respironics California Inc. has initiated a recall of Esprit V1000 and V200 Ventilators, Model V1000 and V200, installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits. These devices were manufactured and distributed from December 21, 2012 to July 9, 2014.

The 3rd Generation Power Supplies are installed in Esprit V1000 and V200 Ventilators and are also sold as 3rd Generation Power Supply Repair Kits. A part in the 3rd Generation Power Supply may prevent the ventilator from using AC power (electricity from a wall socket) or may fail and prevent the ventilator from switching back to AC power after using battery power. Additionally, if a battery is not present or is used up, the ventilators will not work.

Failure of the power supply may cause the ventilator to shut off, which may result in too much carbon dioxide in a patient’s blood, not enough oxygen in the blood, or death.

There have been no reports of death or serious injury related to this potential problem.

The Esprit V1000 and V200 ventilators provide constant or periodic breathing help for adults and children, including newborns. These devices are used in hospitals and other health care settings.

A Philips field service engineer, trained service provider, or distributor will contact customers to schedule a replacement of the recalled 3rd Generation Power Supply with a 3.1 Power Supply on all Esprit V1000 and V200 ventilators, and all 3rd Generation Power Supply Repair Part Kits.

Philips Healthcare sent an URGENT Field Safety Notice dated September 17, 2014 to all customers who purchased the Esprit V1000 and V200 Ventilators.

The letter recommends that customers and users take these actions:

  • Until the ventilator is replaced, it can still be used according to the directions for use.
  • If the power supply fails during use and the ventilator loses standard electrical current, a different ventilator must be used.
  • Be aware of the warnings from the Esprit V1000 and V200 operator’s manual. When lights and sound alarms occur, including a flashing red light when the battery is low, the patient must be supported by a different ventilator.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection

Solgar, Inc. is voluntarily recalling ABC Dophilus Powder. Testing conducted by the Centers for Disease Control revealed the presence of Rhizopus oryzae in 1.75 oz (50 g) containers of Solgar ABC Dophilus Powder, which may cause Mucormycosis. This is a rare infection that may cause health problems to consumers, particularly pre-mature infants/infants, children, and those with weakened immune systems. It may also occur rarely in people who are otherwise healthy.

Risk factors for developing Mucormycosis include: uncontrolled diabetes; cancer; organ transplant; neutropenia (low white blood cells); skin trauma (cuts, scrapes, punctures, or burns). 

Product recalled has UPC Code: 0 33984 00010 0; Lot# 074024-01R1, 074024-01, 074024-02; Expiration Date 7/31/15

This product was distributed to: AL, AR, AZ, CA, CT, CO, FL, IA, IL, IN, MI, ME, MO, MA, NC, NE, NY, NJ, NV, OH, OK, PA, PR, UT, TN, TX, VT, KY, WI, WA, UK and Israel through pharmacy, retail stores, wholesale, and the internet. The distribution of the product has been suspended while FDA and the company continue to investigate the source of the problem.

Do not consume this product. Susceptible consumers should consult with their physician or health care provider if they have used this product.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death

FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.

The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.

Health care professionals should not change the way they prescribe these drugs at this time. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

FDA notified health professionals and their medical care organizations of the Class 1 recall of the Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through August 22, 2014. The recalled products have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected, which could lead to serious health problems or death.

The Nellcor Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children, and premature babies that weigh at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.

Covidien sent an Urgent Field Corrective Action letter dated October 3, 2014 to its customers. A Covidien representative will update the software on the ventilators as soon as possible. To receive the software update, complete the acknowledgement and receipt form attached to the correction letter. Fax it to the Covidien contact found on the form.

Customers may continue to use these ventilators until Covidien updates the software, as long as two gas sources are connected to the ventilator at all times. See the recall notice at the link below for other Covidien reminders and instructions from the Corrective Action letter. 


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity

The power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used.

Hospira received a total of 20 reported incidents including one report of smoke and found that the GemStar Infusion Pump was operating on battery power while connected to the 3VDC power supply. There were no reports of injuries or death.

The firm noted that all 13,002 units distributed worldwide, with 5,687 of those units distributed in the U.S., may fail. The use of the recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death. In oxygen-rich environments, an electric shock or spark from a malfunctioning pump could cause a fire.

The GemStar Supply is an accessory that provides power to the GemStar Infusion Pump. The power supply converts alternating current (AC) voltage of 120 or 240V to Direct Current (DC) voltage of 3.3 Volts. Hospira GemStar Infusion Pumps are used to deliver controlled amounts of fluids including medicines, blood, blood products, nutritional foods, and other mixtures, into a patient’s body in controlled amounts. Hospira Gemstar Infusion Pumps are used in hospitals, for outpatient care, and for home care.

Remove the power supply from service. If you (or a potential user) believe that the power supply is damaged for any reason. Contact Hospira Global Complaints at 1-800-441-4100 to report the concern.

Hospira sent an “Urgent Medical Device Correction” letter dated February 3, 2014 to all direct customers. The letter outlined the problem and the steps to be taken.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin

Richard-Allan Scientific discovered defective products returned from several customers were found to have from 0 percent to 3 percent Formalin content instead of the required 10 percent.  A too-low or too high concentration of Formalin will not properly preserve or can damage tissues.

This recall was initiated on September 17, 2014 and includes 10 percent Neutral Buffered Formalin manufactured on July 18, 2014 and distributed between July 18 - September 17, 2014.  Richard-Allan Scientific sent an Urgent Medical Device Recall letter dated September 10, 2014 to all customers followed by a second letter dated October 3, 2014 with additional information.

Richard-Allan advises customers/users to:

  • Immediately stop using the defective product.
  • Upon identifying the defective lots, notify Richard-Allan Scientific of the quantity and the preferred disposal/return method.
  • If the defective product is being disposed of, evidence of disposal is required to be sent to Richard-Allan Scientific.
  • If the defective product has been used with no issues, notify Richard-Allan Scientific of the quantity that is unavailable for return or disposal.
  • Immediately complete and return the acknowledgement form that is attached to the Urgent Medical Device Recall letter.

The firm sent a follow-up letter dated October 10, 2014 that recommended attending physicians of all patients that could be affected be contacted in order to determine if further testing is required for their patients.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria

Including brand names: Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings

Nutek Disposables, Inc. initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam's Club, Family Dollar, Fred's, and Diapers.com.

After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of the bacteria Burkholderia cepacia (B. cepacia), in some of these products. B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia.

As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.

The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility.

Consumers who have purchased this product can return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-855-646-4351, Monday through Friday, 10 AM – 4 PM EDT. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Intravia Containers by Baxter: Recall - Particulate Matter

Baxter International Inc. announced it is voluntarily recalling two lots of INTRAVIA containers in the U.S. and Canada due to complaints received for particulate matter found inside the fluid path. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition.

INTRAVIA containers are empty plastic containers with PVC ports and a sterile fluid path. The recalled lots are INTRAVIA Container, 150 mL Capacity, Lot Number UR13D15112, Product Code 2B8011, distributed to customers between April 26, 2013 and June 20, 2013; and INTRAVIA Container, Empty 500 mL Capacity, Lot Number UR13K14095, Product Code 2B8013, distributed to customers between November 27, 2013 and March 10, 2014. Unaffected lot numbers can continue to be used according to the instructions for use.

Customers are being directed not to use product from the recalled lots. Recalled 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.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up

Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The affected products are: boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength.

Consumers who intentionally avoid using Ibuprofen due to allergy, or other medical conditions, are advised that they may have inadvertently purchased Ibuprofen 200mg softgels, believing it was Naproxen Sodium 220mg tablets. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. The firm has not received any reports of adverse events related to this recall.

The recalled Assured brand drug products were distributed nationwide to Dollar Tree and sold via the Dollar Tree retail stores and internet site.

Contract Packaging Resources is notifying its distributors and customers directly and arranging for replacement of all recalled products. Consumers may return the recalled products to the place of purchase or contact the firm by phone at 336-252-3422, on Monday – Friday from 8:00 am to 4:00 pm (Eastern).


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter 

Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

This lot (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) was distributed nationwide from May 2014 through June 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions. 

Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. This recall is being carried out to the medical facility/retail level (both human and veterinary). Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of these products in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-877-546-5069 between the hours of 8am to 5pm ET, Monday through Friday. 


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. The issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. To date there have been no reports of adverse events associated with this issue for the impacted lots.

The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. The root cause is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. The manufacturing issue that caused this incident has been addressed.

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-861-6221 between the hours of 8am to 5pm ET, Monday through Friday.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED unit

Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.
Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit.  The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.

These electrodes will not connect with Philips FR3 or FRx AED units, and in the case of the use of Covidien defibrillation electrodes with the Philips FR3 AED units, could result in a delay of therapy. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the compatibility issue until the AED must be used. This may result in a delay in therapy. 

Covidien alerted customers to the this issue by letter on September 18, 2014, and has revised labeling to clarify that use of these electrodes is incompatible with Philips FR3 and FRx AED units. There are a total of 644,460 electrodes affected by this safety alert. See Firm Press Release for electrodes affected including additional brands.

Philips FR3 and FRx AED units should only be used with the Philips brand electrodes specified in the equipment manual. Customers should review the use of Covidien defibrillation electrodes in their facility to assure that Covidien electrodes are not placed for use with Philips model FR3 or FRx AEDs.
For further information or to report a problem, please contact Covidien Quality Assurance at 1-800-962-9888, option 8, then extension 2500 between the hours of 8 a.m. and 5 p.m. (eastern) or email Mansfield.productmonitoring@covidien.com


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance

Oregon Compounding Centers, Inc., also called Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance. The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall following a recent inspection which identified an issue with sterility assurance. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

All recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014 through September 22, 2014, and distributed to health care facilities, physicians, and patients in two states, Oregon and Washington. The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.

Users or recipients of these products should immediately discontinue use and return the recalled unexpired products. To return product or request assistance related to this recall, users should call 503-685-6111 or 877-585-6111, Monday through Friday, from 9:30 a.m. to 1 p.m. and 1:30 to 5:30 p.m. PDT.


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CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure

FDA notified health professionals and their medical care organizations of a Class I Recall of these products. There is a potential for damage to their power cord adaptors which can cause loss of power and complete shut off. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. Ventilator shut-off from power failures may lead to serious patient injury or death. The company has received 256 reports of the incident with no reported injuries or deaths.

The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg).  They are used in hospitals, during transport of a patient and at home to provide constant or intermittent respiratory support. The recalled products were manufactured from May, 2009 to August 2014 and distributed from December 10, 2010 to August 6, 2014.

CareFusion sent customers a Product Recall Notice letter on August 8, 2014. The letter identified the product, problem and actions to be taken. The letter also said that two new power adaptor accessory kits for the ReVel and EnVe ventilators would be sent to correct the problem. A complete listing of affected lot numbers may be found in the recall notice.

For questions, call the CareFusion Recall Center at 888.562.6018, Monday through Friday, 7:00 a.m. – 4:00 p.m., Pacific Time.


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ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended

FDA notified health professionals and their medical care organizations of a Class 1 recall of the Stat2 Flow Controller because it was assembled with the wrong internal component. The Flow Controller may deliver fluid at a much higher flow rate than what is set. Use of the affected product may cause serious adverse health consequences, including death.

IV administration sets are used to deliver or remove fluids from the body, with the amount of fluid delivered controlled by a flow controller. The affected item numbers: 011-C9801, 011-C9802, AH7007, B9897, Z2648 and affected lot numbers: 2768416, 2768417, 2758229, 2785379, 2801951, 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL. The recalled product was manufactured from October, 2013 to January, 2014 and distributed from October, 2013 to January, 2014.

On August 19, 2014, ICU Medical Inc. sent an Urgent Medical Device Recall Notification letter to affected customers and authorized distributors. The letter identified the affected product, problem and actions to be taken. The letter advised customers to remove the affected devices from use and return them to ICU Medical, Inc. Questions about this recall may be directed to ICU Customer Service at 866-829-9025 (Option 8), Monday through Friday, 8:30 AM - 4:00 PM Pacific Time.


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Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit

Hospira, Inc. issued a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015. The product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer.

This recall is being carried out to the medical facility/retail level (both human and veterinary).

There have been no adverse events or complaints reported for the affected lot.

Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle.

For additional assistance, call Stericycle at 1-844-861-6215 between the hours of 8am to 5pm ET, Monday through Friday.


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SAM Junctional Tourniquet Accessory (Axilla) Strap/SAM Medical Products: Recall - Potential Clip Failure

SAM Medical Products notified customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT). The company has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use.  

If this piece were to fail in actual use the operator may face a potential delay in using the SJT in the Axilla area. All other indications of the SJT (inguinal hemorrhage and pelvic fracture) are not impacted by this issue.

The SAM Junctional Tourniquet has received 510K clearance for controlling inguinal hemorrhage, axilla hemorrhage, and pelvic fracture stabilization.

SAM Medical Products has notified customers of the voluntary recall by letter and is arranging with its customers to rapidly replace the current axilla straps with an updated version.

For more information or questions related to this notification, please contact SAM Medical Products Customer Service at 1-800-818-4726 or (503) 639-5474 or email at customerservice@sammedical.com.


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Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break

The ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.

Manufacturing Dates:  March 2013 to July 2014
Distribution Dates:  June 2013 to May 2014

Anesthesia circuits deliver a mixture of anesthesia and/or other gases from a mechanical ventilator to a patient. This device is used in hospitals to care for pediatric patients. 

On September 8, 2014, Teleflex Medical sent customers an Urgent Medical Device Recall letter explaining the device problem and actions to be taken.

Teleflex Medical recommends the following actions:  

  • Stop using the devices.
  • Remove the devices from inventory and stop distribution.
  • Return the Recall Acknowledgement Form included with the letter. 
  • Notify any customers who may have received the devices through re-distribution.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling

Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

Ketorolac Tromethamine Injection, USP, 30mg/mL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting, and is supplied in a single-dose vial.

The lot numbers being recalled  - MP5021, MP5024 and MP5025 - were distributed to hospitals, wholesalers and distributors nationwide from September 17, 2014 through October 1, 2014.

Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.  Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Ketorolac Tromethamine Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning

FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product.

FDA learned of this risk from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain high levels of lead. FDA has received one adverse event report of lead poisoning in an 18-month-old child who was given this product.

Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.

The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English.

Parents and caregivers are advised to not purchase or use this product. Anyone using this product or providing it to a child should immediately consult a health care professional.


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Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label.

The review found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.

Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.

Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling

Baxter International Inc. announced a voluntary recall of one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826 (Lot # P318220, NDC # 0338-0709-48) to the hospital/pharmacy/nurse level. The recall is being initiated due to a labeling error on the shipping cartons in a single lot. Shipping cartons labeled for this specific lot number of Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862.

As both products are packaged in 100mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014. There have been no reported adverse events associated with this situation to date.

Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously. Gentamicin Sulfate is an antibacterial drug for intravenous administration.

It is recommended that healthcare professionals carefully review the product label before administering.

Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter

Hospira, Inc. announced a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair, sealed between the tube and the film at the round seal of the unused Administrative Port on the non-print side of the container.

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

The affected lot was distributed nationwide between June 2014 and August 2014 to wholesalers/distributors, hospitals and pharmacies.

Anyone with an existing inventory should stop use and distribution and quarantine the product immediately. 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 additional assistance, call Stericycle at 1-855-201-4337 between the hours of 8am to 5pm ET, Monday through Friday.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Pharmacy Creations Certain Products: Recall – Potential Non-Sterility 

Pharmacy Creations has voluntarily recalled four product lots (see firm Press Release) following testing results conducted that indicated that the product lots may have the potential of not being sterile. Although we cannot be certain that the product subject to the recall is contaminated, to the extent it was, there are serious health implications for the use of contaminated product in all patients which could include development of a life-threatening infection. To date there have been NO reported adverse events associated with the use of the product. 

The prescription preparations were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014 and June 18, 2014 and were mailed directly to patients and physicians. 

Customers should return the recalled product lots. Physicians and patients that have products which are being recalled should stop use and return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. If the sterility of a compounded preparation is compromised, a patient is at risk for infection.

Martin Avenue Pharmacy, Inc. supplied compounded sterile preparations to the offices of licensed medical professionals and individual patients by prescription until 08/20/14 in multiple states including IL, WI, OH, MI, FL, AL, and TX.

Patients and healthcare providers that have product which is being recalled should stop using the products, and follow the instructions in the recall notice. Martin Avenue Pharmacy, Inc. is notifying its customers of this recall by fax, mail, phone or email with instruction on how to return to the pharmacy.

Consumers or health care providers with questions regarding this recall may contact Martin Avenue Pharmacy, Inc. by phone at (630) 355-6400 or toll free (888) 355-6492, Monday through Friday, 9:00 a.m. to 7:00 p.m. Central Time or by e-mail at info@martinavenue.com.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Dermatend Original and Dermatend Ultra: Recall - Safety Concerns

Solace International, Inc. is voluntarily recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage forms, to the distributor/wholesaler level. A mole should be removed under the supervision of a dermatologist. Dermatend is not FDA approved, thus has not been shown to be safe and effective for the uses suggested in the labeling. Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.

Currently, the Dermatend Original and Dermatend Ultra products are used to remove moles, warts and skin tags. Dermatend Original and Dermatend Ultra are packaged in a flexible plastic tubes labeled with the product name in blue letters. All units and lots are affected by the recall.

Solace International, Inc. is notifying its distributors/wholesalers by certified letter and is arranging for the return of all recalled products. Distributors/wholesalers that have Dermatend Original and Dermatend Ultra product, which is being recalled, should return all units and cases to Solace International, Inc. Consumers who purchased Dermatend Original and Dermatend Ultra to remove moles and warts should immediately discontinue use and consult their physician. 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

DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery

FDA notified healthcare professionals of a Class I recall of the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). Also called an External Mandibular Fixator And/Or Distractor and a Bone Plate. DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery.

  • Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.
  • Children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.
  • In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.

There have been 15 reports of injury associated with the use of this device.

The DePuy Synthes Craniomaxillofacial (CMF) Distraction System is an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct birth (congenital) or post-traumatic defects of the jaw by gradually lengthening the bone (distraction).

  • Review their inventory and remove affected lots from stock.
  • Call DePuy Synthes at 1-800-479-6329 for a return authorization number
  • Complete and return the verification in the letter included with the notice.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility

Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths have been reported as of August 21, 2014. Affected products were manufactured from January 9, 2009 to May 19, 2014, and distributed January 2009 to May 2014.

Products were distributed within the domestic (Puerto Rico Commonwealth, Florida State, New York State, US Virgin Islands); and international market (Geographical Area Central America-Costa Rica & Panama; and South America-Colombia).

Customers who have products should stop using. Customed, Inc. is notifying its distributors by mail and arranging for the products return. Customed is requiring distributors to notify any customers who received the product through redistribution. Customers with questions about this recall may contact Ms. Wanda Cotto, Recall Coordinator, at 1-787-801-0100 Ext. 7540, Monday through Friday, 8:00 a.m. – 5:00 p.m., Eastern Time.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold

Product Model Numbers
Gel-E Donut 92025-A, 92025-B, 92025-C
Squishon 2 91033-2

FDA and Children’s Medical Ventures, Monroeville, PA notified health professionals and their health delivery organizations of a class 1 recall of this product due to complaints about visible mold on the outer surface of Gel-E Donut and Squishon 2 gel-filled products. The detected mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds. Cladosporium has been known to cause several different types of invasive infections, including skin, eye, sinus, and brain infections especially in vulnerable populations such as neonates, critically ill patients, and patients with an impaired or weakened immune system. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or allergic reaction. The use of affected product may cause serious adverse health consequences, including death.

These gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body, help ease pressure caused by long periods of stillness and allow for head movement while maintaining a supportive surface.The affected products were manufactured and distributed from July 1, 2012 to December 31, 2013.

On May 28, 2014, Children’s Medical Ventures sent an “Urgent–Field Safety Notice” informing affected customers, end users, and distributors of the problem, actions that should be taken by the customer/product user in order to prevent risks to patients, and the actions planned by Philips/Children’s Medical Ventures to correct the problem.

Please see the Class 1 recall notice below for detailed instructions provided by Children’s Medical Ventures for customers/product users and for distributors.

For questions about this recall, contact Children’s Medical Ventures Customer Support at 412-380-8881.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft

Cook Medical recalled 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices, model Number VRS-6.0-9.0. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare.

The recall affects products manufactured between August 2012 and August 2013 and distributed between March 8, 2013 and July 1, 2014. The recall affects customers in the United States, Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden and Switzerland.

In six cases, customers reported separation of the loop snare from the shaft during use. The separation was caused by the application of lateral force to the snare in an effort to change the shape of the device. In four cases of separation, medical intervention to retrieve the separated snare was required.

Cook Medical notified all customers on July 10 2014 of the recall by letter and has arranged for affected devices to be returned. Customers with questions may contact Cook Medical at 800-457-4500.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use

Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems, model number DPB-125MICRO145 (Part number 7-10003), because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly block blood vessels. There are no reported patient injuries to date.

Affected lot numbers: 100573, 100575, 100674, 100676, 100678, 100680.

The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter through the skin into a patient’s blood vessel. The system is used to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts.

Ninety-four affected devices were manufactured from 05/08/2014 to 05/09/2014.  Forty-eight devices were distributed from 05/16/2014 to 05/20/2014.

On May 27, 2014, Cardiovascular Systems sent an “Urgent Medical Device Recall” letter to their customers. The letter identified the problem and the specific products affected by the recall. The letter advises customers to:

  • Remove affected devices from service.
  • Complete and return a “Customer Acknowledgement Form.”
  • Return affected devices to Cardiovascular Systems
  • For more information, contact Cardiovascular Systems Customer Service at 1-877-274-0901.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter

Baxter International Inc. announced a voluntary recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall was initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process. Lot numbers affected by this recall are C940700 and C940841. The affected lots were distributed to customers between May 30, 2014 and July 9, 2014.

Intraperitoneal administration of a product with particulate matter may cause local inflammation with foreign body reaction or result in adhesion formation. The particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

The recalled products were distributed to dialysis centers, facilities, distributors, and patients in the United States.

According to the 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.

Baxter notified customers by recall letter to instruct them to locate and remove any affected product from their facility. All patients who received product from the affected lots 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.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter

Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials.

The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.

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 lots listed should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of these recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles

FDA is notifying health professionals and their patients of the voluntary recall of White and Blue-branded tattoo inks and needles due to confirmed bacterial contamination in unopened bottles of inks and on needles included in tattoo kits. FDA is concerned that consumers are continuing to use contaminated inks for tattoos. Similarly packaged tattoo products remain available online and may be marketed by other distributors from the same manufacturer.

Injecting contaminated ink into the skin or using contaminated needles may result in infections at the site of the tattoo that can spread throughout the body through blood. Symptoms of illness include redness, swelling, itching, or blemishes in the tattoo, or pain in the tattoo that does not go away.These infections can be severe and require extensive treatment with antibiotics, hospitalization, or surgery. Sepsis, a potentially life-threatening body-wide infection of the blood, may result. Once the infection has healed, the area may remain permanently scarred. Anyone receiving a tattoo is at risk for infection, but particularly vulnerable are those with pre-existing heart or circulatory disease, diabetes, or patients with compromised immune systems.

On July 11, 2014, White and Blue Lion, Inc. recalled tattoo inks sold separately and in kits, and tattoo needles in kits. See firm press release for lot and batch numbers. The inks carry a dragon logo on the packaging. The contaminated inks are sold singly and in sets containing from five to 54 or more bottles of ink of various colors. The contaminated inks are also sold in kits containing needles and tattooing machines. Some of the sets are intended for permanent makeup, as well as for traditional body tattoos. Containers may be marked with “Lotch” [sic] and Batch numbers, and “Date produced” and “Best if used by” dates.

FDA is warning consumers not to use tattoo inks and tattoo kits that have been recalled or that have similar packaging to those that have been recalled. Consumers who purchase tattoo inks or who seek tattooing should examine the ink bottles and determine whether the inks and/or kits are part of the recall.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.

The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. Patients with a 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.

Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

RegenESlim Appetite Control Capsules: Recall - Presence Of DMAA

Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its RegenESlim appetite control dietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.

RegeneSlim is purchased by and distributed through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and retail sales. RegeneSlim is packaged in approximately 3 ½” by 3” green and white sachets that contain 2 capsules, with the name RegeneSlim displayed prominently on the front of the sachet.

Consumers who have purchased affected RegeneSlim lot numbers are advised to immediately stop using the product and return it to the place of purchase. Consumers with questions may contact the company at 1-949-281-2600 between the hours of 9 a.m. and 6 p.m. PDT. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using RegeneSlim.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler

The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.

The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection.

FDA recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance and instead use the list of FDA approved fillers.  In addition, patients who have received treatment with Expression as a dermal filler should be monitored for adverse events and referred for corrective treatment when appropriate.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates

Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. 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 goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

Lidocaine is packaged 10 units per carton / 180 units per case in single-dose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 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 is notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for return processing. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET).


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging

American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated

Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy.

Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with “IP 465” printed on one side.

Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Oxcarbazepine Tablets, 300 mg, with outer carton NDC#: 62584-143-0 and individual dose NDC#: 62584-143-11, Lot #142544, Expiration Date, 02/2016. The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '184' on one side and scored on other side.

These hospital unit dose products were distributed nationwide beginning June 20, 2014

Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers.

Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product.

For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance

FDA is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

FDA investigators inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk. The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions.

NuVision’s products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.

Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance

The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. To date, FDA is not aware of reports of illness associated with the use of these products.

Unique Pharmaceuticals’ products were distributed nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.

FDA investigators conducted two recent inspections of the Unique Pharmaceuticals facility and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483s issued April 4, 2014 and June 20, 2014). These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their health care professional.  The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Unique Pharmaceuticals' products to the FDA’s MedWatch Adverse Event Reporting program:


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination

Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015 . This action is due to one confirmed customer report where particulate was identified within the solution of the primary container. The particulate was identified as a filamentous-like structured particulate indicative of mold. Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak.

Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure. Hospira has not received reports of any adverse events associated with this issue for this lot to date, and has not identified any quality issues with retention samples for this lot.

The product is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. The product is packaged in 1000mL flexible containers, 1 container per overwrap, and 12 overwrapped containers in each case. The lot number is located in the upper left hand side of the primary container. This lot was distributed nationwide from December 2013 through February 2014 and was distributed to hospitals, clinics, wholesalers and distributors.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-8457 between the hours of 8am to 5pm EST, Monday through Friday, to arrange for the return of the product.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled

FDA notified health professionals of a class 1 recall of this product due to one lot of 3.0mm sized connectors, Lot #2553426, which were mislabeled in packages as 3.5mm. The affected products were distributed in November 2013.

The connector is used to attach the endotracheal tube to the patient breathing circuit for respiratory support.

On April 10, 2014, Smiths Medical sent an Urgent Medical Device Recall to all affected customers. Customers should examine their inventory, remove all affected products and returned the completed Response Form and affected products to Smith Medical. Customers with questions were instructed to contact Smiths Medical’s Customer Service Department at 1-800-258-5361


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks

FDA is warning consumers not to purchase or to use Thorne Research’s Captomer or Captomer-250, marketed as a dietary supplement for heavy metal toxicity and heavy metal chelation therapy. The products list DMSA (meso-2, 3-dimercaptosuccinic acid), as an active ingredient, which is contained in an FDA-approved prescription product indicated for the treatment of lead poisoning in children. FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification. There are no FDA-approved OTC chelation products.

Procedures involving chelation agents carry significant risks and should be performed only under medical supervision. 

The company has received several adverse event reports associated with these products. Thorne Research has agreed to voluntarily recall the products. For recall information, contact Thorne Research.

FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload.

Do not purchase or use Captomer or Captomer-250. Avoid all products offered over-the-counter (OTC) for chelation or detoxification.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. Hospira has attributed the embedded particulate to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventive actions.

Administered solution with particulate - depending on the particle size and number - could block administration of the drug to the patient, causing a delay in therapy. Particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

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

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 1-888-656-6380 (M-F, 8 a.m. - 5 p.m. ET).


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage

NDC issued a recall of all HydroFinity Hydrophilic Guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. Vessel occlusion may necessitate surgical intervention to resolve. Two cases were reported where the polymer jacket separated from the device and embolized. One case required surgical intervention.

The HydroFinity Guidewire is a product developed and manufactured by NDC and distributed by Covidien. It is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating intended for use in catheter placement and other procedures to treat vascular diseases.

Covidien alerted customers by letter on June 3, 2014 and is recalling all product. Unused product should be returned to Covidien.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication

FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk. 

Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer. 

Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing

A Class I Recall was issued for all Flexi-Seal CONTROL Fecal Management System Kits. No 510k application was submitted to FDA. In addition, ConvaTec received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon. Use of this device may lead to: rectal damage (necrosis/ perforation/ulceration or bleeding); expulsion of the device and/or leakage; fecal soiling of bed linen/incontinence pads leading to skin deterioration around the anus, peeling skin, and raw, irritated lesions due to skin contact with fecal matter; and death.

This device is used in health care facilities to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.

On April 29, 2014, ConvaTec Inc. sent an Urgent Voluntary Medical Device Recall letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Stop distributing/using the recalled device, and quarantine the devices in your possession.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems

The FDA became aware of problems associated with the quality of mammograms performed at Big Sky Diagnostic Imaging, LLC, located in Butte, Montana. The FDA worked with the American College of Radiology (ACR) as it performed a routine review of a sample of mammograms performed by Big Sky Diagnostic Imaging, LLC that included images taken between November 20, 2011 and November 20, 2013. Results from that review included poor quality mammograms. The FDA will continue to monitor this issue and keep the public informed as new information becomes available.

This does not mean that the results of the examinations were inaccurate, but it does mean that patients should speak to their health care providers about whether their mammograms need to be repeated.

Under federal law (Mammography Quality Standards Act or MQSA), the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet these standards for mammography quality. As of Feb. 6, 2014, the facility is no longer performing mammography. The ACR revoked its accreditation and its MQSA certificate is no longer valid.

The FDA recommends the following for patients who had a mammogram at Big Sky Diagnostic Imaging, LLC any time after Nov. 19, 2011:

  • If you have had a mammogram at another MQSA-certified facility since then, you should follow the recommendations from that facility.
  • If you have not had a mammogram at another MQSA-certified facility since then, follow these guidelines:
    • Talk with your current health care provider as soon as possible about the need for a follow-up exam.
    • If your health care provider recommends you have another mammogram, it should be done at an MQSA-certified facility to ensure quality and accuracy. A database is available online.
    • If your health insurance will not pay for a repeat mammogram, you can call the National Cancer Institute’s (NCI) information service at 1-800-422-6237 for a listing of MQSA-certified facilities near you that will provide free or low-cost mammograms.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive

Includes: Benicar, Benicar HCT, Azor, Tribenzor, and Generics

FDA has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients (see previous alerts linked below). FDA believes the benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks.

FDA safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients. To evaluate these findings, FDA reviewed additional studies, including a large study in Medicare patients.

Patients should not stop taking olmesartan or any blood pressure medication without first discussing it with their health care professional. Recommendations for use of olmesartan remain the same, but FDA will require information about some of the studies to be included in the drug labels.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

Sold under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.

FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.  

These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels.

The hypersensitivity reactions may occur within minutes to a day or longer after product use.  The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.  They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.   

Based on the information reported to FDA, it cannot be determined if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both. FDA is continuing to monitor and evaluate this safety issue, and will work with manufacturers regarding any future label changes that would address the risk of severe hypersensitivity reactions.

Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain

FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.

Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.

In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. See further details in the FDA Drug Safety Communication.

Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain.

  • Use a teething ring chilled in the refrigerator (not frozen).
  • Gently rub or massage the child’s gums with your finger to relieve the symptoms.

FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful. FDA recommends following the American Academy of Pediatrics’ recommendations to help lessen teething pain.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved

FDA alerted health care professionals not to use injectable vitamin drug products distributed by Medical Supply Liquidators LLC in Clive, Iowa, with “Sunshine Labs” on the label. These products are manufactured by Compound Brothers Dominicana (also known as CB Inc.) in the Dominican Republic and sold as prescription injectable nutritional supplements. FDA has not approved these products and cannot be assured of their safety, effectiveness, or quality.

All lots of non-expired products from Compound Brothers Inc. and labeled as Sunshine Labs are being recalled by Medical Supply Liquidators. See the FDA Statement for a listing of all affected products.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter

Bristol-Myers Squibb Company issued a voluntary recall of six lots of Coumadin for Injection, 5 mg single-use vials in the U.S. Visible particulate matter was found in a small number of Coumadin for Injection unreleased samples. Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur.

To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue.

Coumadin for Injection 5 mg single-use vials is packaged in cartons of six vials. The affected Coumadin for Injection includes the following six lots distributed to hospitals and pharmacies from November 2011 through January 2014: 201125, 201126, 201127, 201228, 201229, 201230.

Coumadin for Injection was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not impacted by this recall.

Anyone that has Coumadin for Injection which is being recalled should stop use and distribution and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for return of remaining stock. Bristol-Myers Squibb has issued recall communications to health care professionals and other customers involved and is arranging for return of all recalled products


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury

Interlink Injection Sites, Catalog Number 46913
SmartSite Injection Sites, Catalog Number 46914
Interlink Injection Sites, Ventricular, Catheter, Catalog Number 46915
SmartSite Injection Sites, Ventricular Catheter, Catalog Number 46916
Interlink Injection Sites, Lumbar Catheter, Catalog Number 46917

FDA notified healthcare professionals of a Class I recall of Medtronic Duet External Drainage and Monitoring System. The firm recalled the device because the patient line tubing may separate from the patient line connectors. According to the firm, the patient line is more likely to disconnect during frequent handling, such as connections where injections or sampling may frequently occur.

The device failure may result in air within the skull (pneumocephalus), infection (such as meningitis, ventriculitis, encephalitis) and over/under drainage of the CSF that may contribute to serious adverse health consequences, including death. The firm has not received any reports of deaths.

The Medtronic Duet External Drainage and Monitoring System (EDMS) externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP). The device is intended to be used only when trained personnel are present to supervise monitoring and drainage 24-hours a day.

The affected products were manufactured from March 15, 2013 through February 28, 2014 and distributed from April 10, 2013 through May 19, 2014.

On June 9, 2014, the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the product, the problem, and the actions to be taken. The firm requested customers to:

  • Stop using the affected product and return all unused devices to Medtronic Neurosurgery.
  • Complete and return the Customer Product Accountability Form enclosed with the letter.
  • If affected products are in use, verify all connections are secure and leak-free per the Instructions for Use.

For questions about this recall, customers may contact the firm’s Director of Quality at 1-805- 571-8725, Monday - Friday, 8:00 a.m. - 5:00 p.m., Pacific Time.


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall  - Inner Catheter May Separate During Use and Cause Injury

Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during use. This may require a procedure to retrieve the separated piece from the patient’s vascular system. There are no reported patient injuries.

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

The Langston V2 Dual Lumen Pressure Monitoring Catheter is used to deliver dye (contrast medium) into a patient’s blood vessels during medical imaging tests (angiographic studies) that allow clinicians to see internal body structures. The device also measures pressure within the blood vessel. Affected devices were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014.  See recall notice for affected lot numbers.


On May 23, 2014, Vascular Solutions sent an "Urgent Medical Device Removal" letter to their customers. The letter advises customers to:

  • Remove affected devices and place them in a secure area.
  • Complete and return the "VSI Account Inventory Form" included with the letter.
  • Returned devices will be replaced by Vascular Solutions. 


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