Millions of Acetaminophen Pills Recalled

Check your medicine cabinet: Millions of bottles of the widely used pain reliever acetaminophen — some sold as long as three years ago — are being recalled because they may contain metal fragments.

The recall affects 11 million bottles containing varying quantities of 500-milligram acetaminophen caplets made by the Perrigo Co. The pills were sold under store brands by Wal-Mart, CVS, Safeway and more than 120 other major retailers, the Food and Drug Administration said. At least two chains — CVS Corp. and SuperValu Inc. — started pulling the pills from store shelves Thursday.

There were no immediate reports of injuries or illness. The contaminated pills included metal fragments ranging in size from “microdots” to portions of wire one-third of an inch long, the FDA said. The FDA could not describe further the type of metal.

Perrigo discovered the metal bits during quality-control checks done after the company discovered its equipment was wearing down prematurely, the FDA said. Agency officials declined to say whether the metal found in the pills caused the damage or resulted from it.

A company investigation turned up metal in roughly 200 pills of the 70 million it passed through a metal detector, according to the FDA.

Consumers who take any of the contaminated pills could have minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote.

Acetaminophen is best known as the drug in products sold under the Tylenol brand. But it is available in typically less expensive generic versions. The drug, along with aspirin and ibuprofen, is one of the most widely used pain relievers available without a doctor’s note.

The recall does not affect Tylenol. Nor should the recall cause a shortage of acetaminophen, the FDA said.

The retail market for the pain relievers is worth more than $2 billion a year, according to Perrigo. The company says it is the world’s largest manufacturer of store-brand nonprescription drugs.

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.

The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc., CVS, Safeway Stores and SuperValu. They typically sell the Perrigo-made pills under their own or other private labels.

CVS will stop selling its own brand of 500-milligram acetaminophen caplets and pull bottles from store shelves nationwide, spokesman Mike DeAngelis said. SuperValu also began removing the pills from its Albertsons, Cub Foods and other stores, spokeswoman Haley Meyer said. Messages left Thursday 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 Thursday with two company spokesmen were not immediately returned.

The FDA declined to identify the source of the raw materials. The agency does not 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, said she did not plan to toss any of the store-brand drugs at home. 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 voluntary recall is considered a Class II recall since it covers products that might cause a temporary health problem or pose only a slight threat of a serious nature.

Consumers with questions can call Perrigo toll free at 877-546-0454.

The FDA did not know in which states the pills had been sold,
but 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.

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 carried out at least 32 other product recalls since 1993, according to FDA records. As recently as May, it recalled nearly 59,000 bottles of a 500-milligram combination pain-reliever and sleep aid that contains acetaminophen because of contamination with acrylic mirror particles.