Acetaminophen recall affects Ky., Ind.Nov 9, 2006 | The Courier-Journal Stores in Kentucky, Indiana and elsewhere pulled store brands of acetaminophen off their shelves yesterday after a major manufacturer of the widely used pain reliever recalled 11 million bottles.
Perrigo Co. issued the voluntary recall after discovering that some pills were contaminated with tiny metal fragments — ranging in size from “microdots” to portions of wire one-third of an inch long, the U.S. Food and Drug Administration said.
State health authorities in Kentucky and Indiana said they knew of no cases of injuries or illness linked to the pills. Nor were there immediate reports elsewhere, the FDA said.
Kroger, Wal-Mart, Meijer and CVS are among the more than 100 retailers that buy acetaminophen, aspirin and other drugs from Allegan, Mich.-based Perrigo and sell them under their own labels.
Those companies said they were removing the suspect bottles, all containing 500-milligram caplets of acetaminophen, from their shelves. Some stores were also programming cash registers not to sell the products.
Customers who bought Perrigo-made bottles can return them for refunds or exchanges, the retailers said.
The recall should not cause a shortage of acetaminophen, the FDA said. The over-the-counter drug is best known as the ingredient in Tylenol-brand products, but is widely available in generic versions.
“We’ve got plenty of acetaminophen that’s not part of this recall,” said Stacie Behler, spokeswoman for Meijer Inc., which has eight stores in Kentucky and 27 in Indiana.
Consumers who take 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.
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.
Perrigo said the pills contained raw material purchased from a third-party supplier and affected 383 batches.
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.
Perrigo bills itself as the world’s largest manufacturer of store-brand nonprescription drugs. The company had $1.37 billion in sales in the fiscal year that ended July 1.