PRIVATE LABEL OTC DRUGS RECALLED FOR SAFETY ISSUES

Pharmacy Times, Volume 0, 0

The FDA announced a nationwide recall of private labelacetaminophen products sold by CVS, Eckerd, Wal-Mart,Kmart, and a number of other chain pharmacies—a moveprompted by safety issues that arose during the manufacturingprocess.

The generic manufacturer of the OTC analgesics,Michigan-based Perrigo Co, voluntarily recalled 383 lots ofacetaminophen 500-mg caplets as a result of small metalfragments found in a small number of these caplets.Although the caplets were destined for distribution undervarious store brands throughout the country, FDA officialssaid they received no patient complaints or reports of illnessor injuries associated with the recalled products. Theagency described the probability of serious adverse healthconsequences as "remote" but acknowledged that, "if aconsumer were to swallow an affected caplet, it couldresult in minor stomach discomfort and/or possible cuts tothe mouth or throat."

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