SmartLipo365 is voluntarily recalling all lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA’s analysis found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.
Category Archives: Food & Drug Recalls
Voluntary Recall Notice for Zatarain’s Red Beans and Rice Original due to Possible Health Risk from Undeclared Ingredients
Zatarain’s is initiating a voluntary recall of 8 oz boxes of Red Beans and Rice Original with a “BEST BY” date of JUL 31 16Z distributed in the Midwest and Eastern regions of the U.S. The Red Beans and Rice Original product may actually contain Creamy Parmesan Rice Mix with dairy ingredients.
FDA permits marketing of fecal continence restoration system
The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
FDA proposes tanning bed age restrictions and other important safety measures
Today, the U.S. Food and Drug Administration announced important proposed steps to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning.
FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes
The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Trader Joe’s Issues Voluntary Recall of Triple Ginger Brew
Trader Joe’s of Monrovia, CA is issuing a voluntary recall of all codes purchased from 11/9/15 through 12/14/15 of Triple Ginger Brew (SKU 51857) due to reports of unopened bottles potentially bursting. Although the ginger brew does not pose a health risk if consumed, all product has been removed from store shelves and destroyed. No injuries or illnesses have been reported to date.
Stella & Chewy’s Voluntarily Recalls Frozen Dinner Morsel Products Due to Possible Health Risk
Stella & Chewy’s is voluntarily recalling four of its products sold in the U.S. and Canada due to concerns of a possible presence of Listeria monocytogenes. The recall affects a total of 990 cases (964 cases in the U.S and 26 cases in Canada).
FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.