Firm recalls pain pills sold at CVS, Wal-Mart, elsewhere

CVS pharmacies, Wal-Mart stores, and other retailers nationwide whisked generic acetaminophen off shelves yesterday in response to a recall of 11 million bottles of the pain reliever by its manufacturer.

The recall affected acetaminophen in 500 mg strength manufactured by Perrigo Co. , a maker of generic over-the-counter drugs based in Allegan , Mich. Its products are distributed through dozens of big and small retailers and wholesalers under store-brand labels.

The Food and Drug Administration said the recall was triggered after Perrigo discovered metal fragments in about 200 caplets. The recall was voluntary, meaning it was initiated by the manufacturer in consultation with the FDA.

Perrigo discovered the problem after realizing its manufacturing equipment was wearing down faster than expected. It passed 70 million pills through a metal detector and found fragments ranging in size from "microdots" to slivers 8 millimeters in length, the FDA said. The agency did not say when the problem was detected.

The FDA reported no illnesses or injury related to the recall and called the probability of a serious health problem "remote." Consumers who swallow a tainted tablet could experience "minor stomach discomfort" or "possible cuts to the mouth or throat," the agency said.

The FDA said it and Perrigo were still investigating the issue and company executives did not return telephone calls seeking comment. CVS and Wal-Mart declined to discuss details of the recall and referred media calls to Perrigo.

"A block has been placed in our point-of-sale system to prevent sales of these items, and all product is being removed from our store shelves," CVS said in a statement. It said other strengths and brand names of acetaminophen remain available.

Wal-Mart said it had also blocked sale of Perrigo acetaminophen at check-out lines and removed it from shelves. It said the acetaminophen was sold under the label Equate Extra Strength Pain Reliever .

The FDA said the recall would not cause shortages of acetaminophen, a common pain reliever that is the main ingredient in Tylenol . Consumers who want 500 mg strength can buy lower strengths and increase the dose, it said. Consumers can check a list of recalled lot numbers on the FDA's website, fda.gov. Consumers seeking more information can also call Perrigo's recall hot line, 877-546-0454.

Christopher Rowland can be reached at crowland@globe.com.