Category Archives: Food & Drug Recalls

FDA approves Topamax for migraine prevention in adolescents

Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.

FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B

The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

Glaxosmithkline Recalls Alli®

laxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all alli® weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic alli®. GSK is conducting an investigation and is working with the knowledge of the U.S. Food and Drug Administration (FDA) on this retailer level recall.

Macadamia Nut Allergy Alert and Voluntary Recall of 15-Count Boxes of Chocolate Chunk LUNA Bars Due to Package Mislabeling

Clif Bar and Company is initiating a voluntary recall today of a small amount of 15-count boxes of Chocolate Chunk LUNA Bars that were shipped to limited stores nationwide. These 15-count boxes include Chocolate Chunk LUNA Bars made with macadamia nut butter, but the wrappers do not include macadamia nuts in the ingredient list or allergen statement.

Pure Edge Nutrition, LLC Issues Voluntary Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein

Toms River, NJ, Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.

New Life Nutritional Center Issues Voluntary Nationwide Recall of Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplements Due to the Presence of Undeclared Sibutramine and Phenolphthalein

New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.