News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
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Tuesday, October 12, 2010
FDA : Recent Recalls
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The folks at the FDA have been busy the past several weeks. Here's a short list of recalls:
Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa):The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy.Link.
Pfizer Consumer Healthcare Issues Voluntary Recall of One Lot of ThermaCare HeatWraps Menstrual Product The company said it is taking this precautionary step after finding a potential for a leak of the components contained in the wrap, which could cause skin injury such as irritation or burn. Link
Recall of AROM-X Capsules, AROM-X UTT Liquid, AROM-XL Liquid, 4-AD Capsules and Decavol Capsules Marketed as a Dietary Supplements Containing ATD: FDA's states that the ingresidnets 1,4,6 etioallocholan-dione do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.
Recall of Reversitol a Product Marketed as a Dietary Supplement Containing ATD: FDA has requested that iForce Nutrition inform consumers that adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. iForce Nutrition has not received any adverse event reports nor are they aware of any adverse events associated with the use of these products. Link.