Manufacturer Recalls Millions of Bottles of Acetaminophen

Nov. 9, 2006 — -- A large drug manufacturer recalled 383 lots -- or 11 million bottles -- of the pain medication acetaminophen today after discovering that metal fragments contaminated some pills.

Perrigo Co. said it discovered the metal fragments, which ranged in size from "microdots" to portions of wire one-third of an inch in length, during quality-control checks. However, the Food and Drug Administration said Perrigo began investigating only after realizing its pill-making equipment was wearing down prematurely.

Since 2001, Perrigo has issued 23 separate product recalls, according to an FDA statement.

The company informed the FDA of the contamination Nov. 1, eight days before the recall.

Acetaminophen, which is widely available in generic versions, is commonly distributed under the brand name Tylenol. The FDA said the recall would not affect Tylenol.

FDA officials said the recall affects a relatively small number of the overall lots and as of yet, there have been no reports of injury or illness related to the recalled pills. According to the FDA, the pills had already reached retail shelves and may have been sold to consumers; the agency suggested that pills within three years of their expiration dates could be contaminated.

In a statement released Thursday afternoon, Perrigo said the source of the metal particles was traced to a third-party supplier. The statement also said the company's quality-control system identified metal particles in about one of every 400,000 caplets screened.

FDA officials said there is little reason for concern.

"We believe there is only a remote likelihood of serious consequences from the use of these products," said Dr. Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research.

"The thing physicians would be most concerned about would be bleeding as a result of metal coming into contact with the gastrointestinal tract," he explained. "We believe the possibility of that happening is remote."

The Allegan, Mich., company has disclosed a list of the store brands and lot numbers affected by the recall. However, neither Perrigo nor the FDA has yet to provide the list of states in which the affected pills may have been available on shelves.