WASHINGTON (AP) – A pill designed to give people relief from headaches is instead causing them.

Consumers are having to read the fine print on bottles of acetaminophen to see if the ones in their medicine cabinet are being recalled because of possible contamination with metal.

Perrigo Co. said Thursday it was recalling 11 million bottles of acetaminophen after finding bits of metal, including portions of wire as long as one-third of an inch, in some of the 500-milligram pills it made.

The company is no household name, but it makes and sells acetaminophen to more than 120 of America’s best-known retailers, including Wal-Mart, CVS and Safeway. Those companies in turn sell Perrigo products under their own or other private labels.

There were no immediate reports of injuries or illness. Still, at least two of the companies have begun yanking the Perrigo 500-milligram acetaminophen pills from store shelves.

The Food and Drug Administration warned that consumers who take any of the contaminated pills could suffer minor stomach discomfort or possible cuts to the mouth and throat. Even though the risk is remote, anyone who suspects they have been injured should contact a doctor.

The contaminated pills included metal fragments, some as small as “microdots.” The FDA could not describe further the type of metal.

Stores apparently sold some of the recalled pills as long as three years ago. In interviews, consumers said they would toss any recalled pills they found at home, but didn’t plan to swear off generic versions of the same drug used in Tylenol.

Tylenol, typically more expensive than generic acetaminophen, was not involved in the recall. Nor are any other manufacturer’s products, or pill sizes other than Perrigo’s 500-milligram acetaminophen caplets.

Kevin Vincent, 44, of Arlington, Va., said his wife buys store brand acetaminophen and he wanted to find out more about the problem.

“If it’s not something that has any chance of recurring, then I really wouldn’t worry,” he said.

Perrigo found the metal during quality-control checks while investigating why its equipment was wearing down faster than normal, the FDA said. Agency officials wouldn’t say whether the metal found in the pills caused the damage or resulted from it.

The company later passed 70 million of the pills through a metal detector and found just 200 or so were contaminated with metal.

The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc., CVS Corp., Safeway Stores and SuperValu Inc.

CVS will stop selling its own brand of 500-milligram acetaminophen caplets and pull bottles from store shelves nationwide, spokesman Mike DeAngelis said. SuperValu said it would do the same at its stores, including Albertsons and Cub Foods. Messages left with the other chains were not immediately returned.

Perrigo, based in Allegan, Mich., said the pills contained raw material purchased from a third-party supplier and affected 383 batches. Messages left with two company spokesmen were not immediately returned.

The FDA declined to identify the source of the raw materials. However, the agency doesn’t suspect the contamination was deliberate, said Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research.

Molly Walsh, 21, a George Washington University student shopping at a CVS pharmacy in Washington, D.C., said she didn’t plan to throw away any of the store-brand drugs that she’d bought to save money. Nor did she plan to stop buying the generic products.

“It’s still going to be cheaper and I’m still going to be broke after the recall,” Walsh said.

The FDA didn’t know in which states the pills had been sold, but instead recommended that customers determine whether products they bought are being recalled by checking the store list on the FDA Web site, http://www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html, and the batch list, http://www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html.

The batch numbers appear on the container’s label. Consumers with questions can call Perrigo toll free at (877) 546-0454.

It wasn’t immediately clear where Perrigo made the pills. Its main factories are in the United States and Israel, with secondary plants in the United Kingdom, Mexico, Germany and China.

Perrigo has conducted at least 32 other product recalls since 1993, according to FDA records. As recently as May, it recalled nearly 59,000 bottles of a combination pain-reliever and sleep aid that contains acetaminophen because of contamination with acrylic mirror particles. The company bills itself as the world’s largest manufacturer of store-brand nonprescription drugs.



Associated Press Writer Ann Sanner contributed to this report.

On the Net:

Perrigo Co.: http://www.perrigo.com/

AP-ES-11-09-06 1750EST


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