A major manufacturer of acetaminophen sold by Wal-Mart, CVS, Safeway and more than 100 other retailers recalled 11 million bottles of the widely used pain-relieving pills Thursday after discovering some were contaminated with metal fragments.
There were no immediate reports of injuries or illness. The recall affects bottles containing various amounts of 500-milligram caplets made by the Perrigo Co.
The contaminated pills included metal fragments ranging in size from "microdots" to portions of wire one-third of an inch long, the Food and Drug Administration said. Perrigo discovered the metal bits during quality-control checks after realizing the equipment it uses to make pills was wearing down prematurely, the FDA said.
A company investigation turned up metal in roughly 200 pills, after passing 70 million of the caplets through a metal detector, according to the FDA.
Consumers who swallow any of the contaminated pills could suffer minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote. Anyone who suspects they have been injured should contact a doctor, the agency said.
The FDA posted on its Web site the recalled batch numbers and the dozens of chains supplied by Perrigo, which bills itself as the world's largest manufacturer of store-brand nonprescription drugs. The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc., CVS Corp., Safeway Stores and SuperValu Inc. They typically sell the Perrigo-made pills under private labels.
Perrigo, based in Allegan, Mich., said the pills contained raw material purchased from a third-party supplier and affected 383 batches. A company spokesman did not immediately return a call seeking comment.
Acetaminophen is best known as the drug in products sold under the Tylenol brand, but is widely available in 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 retail market for the pain-relievers is worth more than $2 billion a year, according to Perrigo.
The recall does not affect Tylenol. The recall should not cause a shortage of acetaminophen, the FDA 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, according to the FDA.
Consumers with questions can call Perrigo toll free at (877) 546-0454.
The batch numbers appear on the container's label.