Millions of Contaminated Bottles of Acetaminophen Recalled

Michigan-based Perrigo Co. is voluntarily recalling 383 lots of over-the-counter 500-milligram acetaminophen, which will affect roughly 11 million bottles of the popular painkiller. The reason for the recall is the presence of small metal fragments in some of the caplets in question. Perrigo, the world’s largest producer of store-brand drugs and supplements, manufacturers the drug for sale under store brands for more than 100 retailers, including Wal-Mart, Safeway, and CVS.

Perrigo discovered the problem after finding worn-down caplet-making equipment during routine quality-control processes. After discovering the faulty machinery, Perrigo ran 70 million caplets through a metal detector and found that approximately 200 of them contained metal fragments ranging from “microdots” to eight-millimeter lengths of wire.

“To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo,” read a Food and Drug Admisistration news alert issued this morning. “Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however 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. Consumers should consult their physician if they suspect they’ve been harmed by use of this product.”

This is not the first time that Perrigo has issued a product recall–in fact, it’s happened more than 30 times since 1993, according to the Associated Press. The AP also notes that in May the company recalled around 59,000 bottles of a 500-milligram pain reliever and sleep aid with acetaminophen because of contamination with acrylic mirror particles.

The FDA has compiled lists of batches affected (www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html) and stores with brands that may be involved (www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html).

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