Perrigo Co. (Allegan, Mich.), a manufacturer of store-brand, over-the-counter drug and nutrition products, says it is recalling 383 batches--11 million bottles--of store-brand acetaminophen caplets after some were found contaminated with small metal fragments. The batches could have been shipped to 129 chain stores, including Wal-Mart, CVS, Longs Drug Stores, Kroger, Safeway, Dollar General and Save-a-Lot.. Expiration dates range from September 2006 to August 2009. The FDA says the recall only involves 500 mg caplets and will not cause a shortage of the medicine.
The recall only involves generic versions of acetaminophen, not the Tylenol brand of the drug.
"We are taking this measure to maintain the highest possible product quality standards for our retail customers and their store-brand consumers," Perrigo executive v.p. John Hendrickson said in a statement.
The FDA said the metal pieces found range in size from a microdot to a wire fragment 8 mm in length. It said that no illnesses or injuries have been reported, but ingesting the metal pieces could cause minor stomach discomfort, minor cuts to the mouth or throat and bleeding.
The agency believes the risk of the problem is very small, but it couldn't say how many states the contaminated medicine might have been shipped to.
The company said its quality control system detected traces of metal pieces in a small number of the caplets. Apparently, the equipment making the tablets was wearing down sooner than expected.
Sources: FDA, CNN