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0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter

January 23, 2015

Audience: Pharmacy, Risk Manager. [Posted 01/23/2015] ISSUE: Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area....

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Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries

January 21, 2015

Audience: Pediatrics, Plastic Surgery, Dentistry, Orthopedic Surgery, Neurosurgery. [Posted 01/21/2015] ISSUE: FDA is aware of healthcare providers using bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. Reports of serious injuries, such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, have increased the FDA’s concern. While...

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Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected

January 13, 2015

Audience: Risk Manager, Health Professionals, Pharmacy. [Posted 1/14/2015] ISSUE: FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. So far, more than 40 patients have received infusions...

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IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

January 10, 2015

[UPDATED 01/10/2015] Wallcur’s Practi-IV solutions bags are recalled. AUDIENCE: Risk Manager, Health Professionals, Pharmacy ISSUE: The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. These products are for training purposes only. There have been reports of serious adverse events associated with the...

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Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy

January 9, 2015

Audience: OBGYN, Consumer. [Posted 01/09/2015] ISSUE:  FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this...

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Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination

January 2, 2015

Audience: Pharmacy, Hepatology, Infectious Disease. ISSUE: Valeant Pharmaceuticals North America LLC (VPNA) is issued a voluntarily recall of one lot of Virazole (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack to the user level. Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. The risk is higher in patients who are...

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IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients

December 30, 2014

AUDIENCE: Risk Manager, Health Professionals, Pharmacy ISSUE: The U.S. Food and Drug Administration is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. These products are for training purposes only. There have been reports of serious adverse events associated with the use of certain of these products – i.e., Practi IV Solution...

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Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification

December 23, 2014

Audience: Oncology, Pharmacy, Nursing, Risk Manager. ISSUE:  Hospira, Inc. announced today it has initiated a worldwide voluntary recall to the user level of 10 lots of MitoXANTRONE (both human and veterinary), due to confirmed subpotency and elevated impurity levels. Risk factors associated with these types of out of specifications may include the potential for decreased potency which can lead to decreased...

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SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients

December 21, 2014

Audience: Consumer. [Posted 12/22/2014] ISSUE: Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of SLIM-K collected and tested by the FDA was found to contain sibutramine, desmethylsibutramine, and phenolphthalein. Products containing sibutramine pose a threat to consumers besause...

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B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient

December 21, 2014

Audience: Consumer. [Posted 12/22/2014] ISSUE: Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of B-Lipo Capsules collected and tested by the FDA was found to contain lorcaserin, a controlled substance used for weight loss. Adverse health consequences associated with taking lorcaserin...

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0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

December 16, 2014

Audience: Risk Manager, Pharmacy, Nursing. ISSUE: Baxter International Inc. initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter. The issue was...

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Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions

December 11, 2014

Audience: Psychiatry, Dermatology, Pharmacy, Family Practice. ISSUE:  FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia...

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

December 9, 2014

Audience: Health Professional, Pediatrics , Internal Medicine, Consumer. [Posted 12/09/2014] ISSUE: 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...

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Slim-Vie: Public Notification - Undeclared Drug Ingredient

November 26, 2014

Audience: Consumer. [Posted 11/26/2014] ISSUE: FDA is advising consumers not to purchase or use Slim Vie. FDA laboratory analysis confirmed that Slim-Vie contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in...

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

November 25, 2014

Audience: Neurology. ISSUE: 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,...

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

November 24, 2014

Audience: Neurology, Risk Manager, Health Professionals, Pharmacy, Nursing. [Posted 11/24/2014] ISSUE: 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...

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Bee Slim: Public Notification - Undeclared Drug Ingredient

November 24, 2014

Audience: Consumer. [Posted 11/24/2014] ISSUE: FDA is advising consumers not to purchase or use Bee Slim. FDA laboratory analysis confirmed that Bee Slim contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in...

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Bee Thin: Public Notification - Undeclared Drug Ingredient

November 24, 2014

Audience: Consumer. [Posted 11/24/2014] ISSUE: FDA is advising consumers not to purchase or use Bee Thin. FDA laboratory analysis confirmed that Bee Thin contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in...

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Black Storm: Public Notification - Undeclared Drug Ingredient

November 24, 2014

Audience: Consumer. [Posted 11/24/2014] ISSUE: FDA is advising consumers not to purchase or use Black Storm. FDA laboratory analysis confirmed that Black Storm contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower...

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Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient

November 24, 2014

Audience: Consumer. [Posted 11/24/2014] ISSUE: FDA is advising consumers not to purchase or use Super Extreme Accelerator. FDA laboratory analysis confirmed that Super Extreme Accelerator contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood...

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