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.

Physicians on the Alert

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."

Many Stores Involved

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.

Wal-Mart Stores Inc., CVS Corp., Walgreen Co. and Costco Wholesale Corp. are among the companies Perrigo supplies with health care products, according to Securities and Exchange Commission filings.

Wal-Mart and CVS have issued statements indicating that they have blocked the sale of the 500-milligram acetaminophen products that may be affected and pulled them from shelves.

Fred Richman, director of the Division of Compliance Management and Operations in the FDA's Office of Regulatory Affairs, said the FDA's decision to issue the recall only on Thursday was made according to regular investigation procedures.

Cause for Concern?

Some experts said the pattern is a reason for concern.

"Even the FDA is admitting that you can get bleeding [in] your mouth and bleeding [in] your throat," said Dr. Sidney Wolfe, director of the Public Citizen's Health Research Group in Washington, D.C. "When people swallow pills, it is the last thing they expect -- that the pills are going to cut their throat or their mouth up."

Wolfe said the fact that Perrigo has issued numerous recalls in the recent past should be a red flag to government regulators.

"They have had 16 recalls in the last two years, and this year isn't even over," he said. "Of all of these recalls, seven of them have been for acetaminophen, one of the biggest-selling drugs that there is.

"When were they last inspected by the FDA, and how frequently, given their terrible record?" he asked. "Without the legal authority to impose any fines on drug companies for anything, it is not surprising that these kinds of problems continue."

The FDA responded that it last inspected Perrigo in March of this year, and it has inspected the company's facilities a total of seven times between 2001 and 2006. The agency maintained that its compliance oversight has prompted the company to rectify its quality control measures.

Still, some experts suggest consumers should take steps at home to ensure their health.

"Because of the nature of the recall, that there are pieces of metal in medications, consumers should be fairly concerned," said Jennifer Athay, a doctor of pharmacy with the American Pharmacist's Association. "They should be checking medications that they have in their medicine cabinets at home to make sure they are not some of the medications that are affected by this recall."

Others said the contamination is not a cause for worry.

"Frankly, I think that the anxiety that this might cause would be worse than a few fragments of metal that might appear in one or two tablets of acetaminophen," said Paul Doering, distinguished service professor of pharmacy practice at the College of Pharmacy at the University of Florida, and co-director of the Drug Information and Pharmacy Resource Center at Shands in Gainesville, Fla. "I just think there's a whole lot of medication that's going to be thrown away for no real purpose."

Doering said the recall could be complicated by the fact that acetaminophen is sold under many different brand names. He added that he feels the intensity of the FDA response is unwarranted and may be an effort to improve the agency's image in the public eye.

"I don't think it's any secret that the public has lost faith in the FDA, in its ability to protect us, with things like Vioxx and other kinds of tragedies that have occurred," he said.

Still, concerned consumers do have an alternative.

"What I would say, from a very practical pharmacist point of view, is to recommend that patients who rely on acetaminophen products, the active ingredient in Tylenol, stop using any store-brand products and use the name brand until the issue is resolved," said Marsha Millonig, a registered pharmacist and president of Catalyst Enterprises in Eagan, Minn. "For a few dollars per person, this is the safest bet, versus trying to determine if their generic or store-brand acetaminophen was made by Perrigo."

Where to Find Information

The FDA said it would continue to keep the public informed.

"The agency is disclosing as much information as it has in its possession at assist consumers with identifying the affected products as quickly and as effectively as possible. As more information becomes available, we will certainly disclose it," said Throckmorton.

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

Customers can also check whether products they bought are being recalled by checking the store list on the FDA Web site.

For a list of stores where the recalled acetaminophen was sold click here

For a list of acetaminophen batch numbers that are being recalled click here

The batch numbers appear on the container's label.