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

November 21, 2014

Audience: Pharmacy, Nursing, Consumers. ISSUE: 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...

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Intravia Containers by Baxter: Recall - Particulate Matter

November 20, 2014

UPDATED 11/20/2014. Recall Classified as Class I. [Posted 10/25/2014] AUDIENCE: Risk Manager, Health Professional, Pharmacy, Nursing ISSUE: 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...

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Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients

November 20, 2014

Audience: Consumer. [Posted 11/20/2014] ISSUE: REFA Enterprises is voluntarily recalling one lot each of: Forever Beautiful Bee Pollen (UPC # 6333090804632) Forever Beautiful Infinity (UPC # 633090804649) The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Products containing sibutramine pose a threat to consumers...

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

November 18, 2014

Audience: Risk Manager, Anesthesiologist, Surgeon. [Posted 11/19/2014] ISSUE: 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...

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

November 17, 2014

Audience: Consumer, Pediatrics, Emergency Medicine, Family Practice. [Posted 11/17/2014] ISSUE: 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,...

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

November 16, 2014

Audience: Cardiology, Hematology, Surgery. [Posted 11/16/2014] ISSUE: 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...

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Mayhem: Public Notification - Undeclared Drug Ingredients

November 14, 2014

Audience: Consumer. ISSUE: FDA is advising consumers not to purchase or use Mayhem, a product labeled as a dietary supplement that is promoted to increase appetite and muscle growth, because it contains an undeclared corticosteroid and antihistamine. FDA laboratory analysis found that Mayhem contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription...

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V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient

November 5, 2014

Audience: Consumer. ISSUE:  FDA is advising consumers not to purchase or use V26 Slimming Coffee. FDA laboratory analysis confirmed that V26 Slimming Coffee 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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Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients

October 31, 2014

Audience: Consumers. ISSUE: FDA notified consumers not to purchase or use “Ginseng Kianpi Pil,” a product promoted to stimulate appetite, promote weight gain and relieve fatigue, because it contains an undeclared corticosteroid and an antihistamine. FDA laboratory analysis found that Ginseng Kianpi Pil contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a...

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

October 31, 2014

Audience: Risk Manager, Surgery, Emergency Medicine. ISSUE: 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. BACKGROUND: This recall was initiated on September 17, 2014 and...

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