Allegan, MI (Nov. 9)—Over-the-counter drug maker Perrigo Company (www.perrigo.com) issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.

After discovering that its tableting equipment was wearing down prematurely, Perrigo reported the contamination to the US Food and Drug Administration on Nov. 2, 2006. The company told Pharmaceutical Technology that the unusual wear was detected and investigated through the company’s internal quality-control procedures. An investigation found metal particulate contamination and traced it back to a third-party supplier of a raw material.

In the investigation, Perrigo reported, 70 million caplets were passed through a metal detector and 200 caplets were found to contain metal fragments. The size of the particles ranged from "microdots" to 8 mm in length. To date, no serious health effects have been reported, but tablets containing metal particles could cause stomach discomfort and possible cuts to the mouth or throat.