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Acetaminophen

11 million bottles of acetaminophen recalled after metal fragments found

Friday, November 10, 2006 by: Jessica Fraser
Tags: acetaminophen, drug recall, painkillers


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(NewsTarget) Generic drug maker Perrigo Co. announced yesterday that 11 million bottles of the popular painkiller acetaminophen are being recalled because they may contain fragments of metal.

The recall affects bottles of 500-milligram acetaminophen in varying quantities that were sold under store-brand names at retailers such as Wal-Mart, Safeway, CVS and SuperValu. Perrigo says some affected bottles may have been sold as long as three years ago.

Though no injuries have yet been reported, many stores selling the possibly contaminated pills began pulling Perrigo-manufactured acetaminophen from shelves yesterday. The U.S. Food and Drug Administration said 120 other major retailers sold Perrigo-made acetaminophen.

Perrigo discovered the metal fragments during quality-control checks the company performed after it found that its manufacturing equipment was prematurely wearing down, according to the FDA. The agency said contaminated pills contained unidentified metal fragments ranging in size from "microdots" to pieces of wire one-third of an inch long.

An internal Perrigo investigation found that 200 pills out of 70 million tested by being passed through a metal detector contained metal fragments. The company said its acetaminophen pills contain raw materials from a third-party supplier, and the contaminated pills affected roughly 383 batches.

The FDA says the contamination was not deliberate, and the risk of serious injury from consuming affected pills was low. If consumers took contaminated pills, they would possibly suffer minor stomach discomfort or possibly cuts to the throat and mouth, the agency said.

The recall does not affect brand-name Tylenol -- which contains the active ingredient acetaminophen -- and the FDA says the recall should not create a shortage of the generic-brand painkillers.

The FDA was unaware of the states in which the contaminated pills had been sold, and recommended consumers who purchase generic store-brand acetaminophen check a list on the agency's website to determine if their pills could be affected.

A complete store list is available at FDA.gov.

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