11 Million Bottles of Acetaminophen Recalled
Friday, November 10, 2006
Perrigo Co., the nation's largest maker of store-brand drugs for retailers such as CVS, Safeway and Food Lion, is recalling 11 million bottles of the painkiller acetaminophen after finding small metal particles in 200 caplets.
Neither the company nor the Food and Drug Administration has received reports of injuries or illness related to the contaminated product. Ingesting contaminated caplets could cause minor stomach discomfort or cuts in the mouth or throat.
The likelihood of any adverse health consequence is remote, said Douglas Throckmorton, a top FDA official.
With 65 percent market share, publicly traded Perrigo dominates the over-the-counter generic drug industry to the point where, on average, every adult and child in the United States takes a Perrigo-made tablet once every four days, chief executive Joseph C. Papa told analysts during an Oct. 10 conference call.
Perrigo pioneered store-brand drugs and makes generic versions of Pepcid AC antacid, Claritin allergy medicine, Sudafed, NyQuil and Centrum vitamins, among other products, that are sold under more than 100 store brands.
The recall affects 383 lots of 500-milligram caplets packaged in amounts of 24 to 500 pills, with expiration dates ranging from November 2006 to August 2009.
The amount of the painkiller involved is a small fraction of the nation's supply of acetaminophen, and the recall is not likely to create a shortage, Throckmorton said yesterday.
FDA officials said they are still investigating how the pills became contaminated.
The pieces of metal range in size from "microdots" to an eight-millimeter wire. The majority of pieces were the size of two grains of salt, the company said in a press release.
Because acetaminophen has a three-year expiration period, some of the recalled product left retail shelves long ago. Consumers who bought any of the implicated brands of acetaminophen during the past three years should check the lot code printed on the side of the bottle. A list of lot codes involved in the recall can be found at http:/
Perrigo, based in Allegan, Mich., told FDA officials on Nov. 2 that it found the traces of metal after noticing that some of its tablet-making equipment was wearing down prematurely. The company put 70 million pills through a metal detector and found the 200 contaminated caplets.
In a press release, Perrigo said the metal had been traced to a third-party supplier, but company officials did not respond to phone messages or e-mails requesting further details.