ALLEGAN — Perrigo Co. announced Thursday that it’s voluntarily recalling 11 million bottles of the over-the-counter painkiller acetaminophen due to possible contamination. The nationwide recall involves 383 lots of store-brand acetaminophen 500mg caplets.
John Hendrickson, executive vice president and general manager of Perrigo Consumer Healthcare, said the company’s quality control systems noted trace amounts of metal particulate in a very small number of the acetaminophen caplets.
Perrigo immediately began notifying distributors and retailers of the issue and of the steps the company would take to replace the product.
The U.S. Food and Drug Administration said Thursday that it had not received any reports of illness or injuries and had not received any consumer complaints in regards to the product.
“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 cuts to the mouth or throat,” the agency stated in its press release.
The FDA said it doesn’t anticipate that the recall will cause a shortage of acetaminophen.