PRIVATE LABEL OTC DRUGS RECALLED FOR SAFETY ISSUES

Published Online: Monday, January 1, 2007

The FDA announced a nationwide recall of private label acetaminophen products sold by CVS, Eckerd, Wal-Mart, Kmart, and a number of other chain pharmacies—a move prompted by safety issues that arose during the manufacturing process.

The generic manufacturer of the OTC analgesics, Michigan-based Perrigo Co, voluntarily recalled 383 lots of acetaminophen 500-mg caplets as a result of small metal fragments found in a small number of these caplets. Although the caplets were destined for distribution under various store brands throughout the country, FDA officials said they received no patient complaints or reports of illness or injuries associated with the recalled products. The agency described the probability of serious adverse health consequences as "remote" but acknowledged that, "if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat."

Visit ePharmacy Times at www.pharmacytimes.com/articleNewsletter.cfm?ID=4022 for a related story on the recall.




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