FDA Alerts
Ranbaxy Issues Voluntary Nationwide Recall of Atorvastatin Calcium
On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of atorvastatin calcium tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level.
FDA Takes Charge Against Illegal Internet Pharmacies
The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers.
FDA Warning: Serious Adverse Events From Eye Drops and Nasal Sprays Ingestion
The US Food and Drug Administration (FDA) is warning the public that accidental ingestion (swallowing) by children of over-the-counter (OTC; available without a prescription) eye drops used to relieve redness and nasal decongestant sprays can result in serious harm.
FDA Warns Tennessee Company that Online Product Claims Violate Federal Law
The US Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.
FDA Reports Voluntary Recall of all Ameridose Drug Products
The US Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation.
FDA Drug Safety Communication: Mirapex and Heart Failure
The US Food and Drug Administration (FDA) is informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson’s disease and restless legs syndrome.
FDA issues Safety Alert on Intestinomicina
The US Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.
FDA releases preliminary data on arsenic levels in rice and rice products
As part of an ongoing and proactive effort to monitor food safety and address contaminants in food, the US Food and Drug Administration today released preliminary data on arsenic levels in certain rice and rice products.
FDA Issues Painkiller Safety Alert
Watson Laboratories, Inc. notified the public of a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg (Lot Numbers 519406A and 521759A, both with the expiry date April 2014, distributed between 6/27/2012 and 7/18/2012 to wholesale distributors and retail pharmacies nationwide).
FDA issues warning letters to PruTect Rx and Trinity Sports Group Inc
The US Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.