[euglena]

SCIENCE NEWS
November 09, 2006
Perrigo recalls 11 million bottles of pain killer


By Lisa Richwine

NEW YORK (Reuters) - Generic drugmaker Perrigo Co. is recalling 11 million bottles of over-the-counter pain killer acetaminophen caplets after finding metal fragments in some batches, U.S. health officials said on Thursday.

The 500-milligram pills sold as store brands may have been sent to dozens of outlets around the United States, including some owned by Wal-Mart, Safeway, CVS and Food Lion, the U.S. Food and Drug Administration (FDA) said.

No injuries or illnesses have been linked to the products, the manufacturer and the FDA said.


Shares of Perrigo, the world's largest manufacturer of store-brand pharmaceutical and nutritional products, fell 5.6 percent to close at $17 on Nasdaq.

The FDA said in a statement that it believed that based on available information the probability of serious adverse health consequences was remote.

"However, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat," the FDA said.

Acetaminophen is the active ingredient in Johnson & Johnson's Tylenol but also is sold generically by various manufacturers. Tylenol is not subject to the recall.

Consumers should not take the recalled caplets and should consult a doctor if they think they may have been harmed, the FDA said.

Perrigo said it found one in 400,000 caplets may have contained metal traces.

FDA officials could not say if the caplets had been distributed nationwide or were concentrated in some regions.

The agency urged consumers to check its Web site for a list of stores that Perrigo supplied. It also provided numbers for each of the recalled 383 batches and said consumers could check the product label for a matching number.

The stores can be found at www.fda.gov/oc/po/firmrecalls/perrigo/p ... tlist.html, while the batch numbers are online at www.fda.gov/oc/po/firmrecalls/perrigo/p ... hlist.html.

CVS Corp. said it would stop selling certain size packages of its CVS brand acetaminophen 500-milligram caplets until further notice.

Agency officials said they and Perrigo were investigating the source of the metal and had no reason to suspect the caplets had been intentionally contaminated.

Perrigo said it had traced the source of metal fragments to a third-party supplier, which it did not name.

Some of the caplets were made as long as three years ago with expiration dates ranging from September 2006 to August 2009, FDA officials said.

Perrigo discovered the problem after finding some manufacturing equipment was wearing down prematurely, the FDA said. The company passed 70 million caplets through a metal detector and found about 200 contained metal fragments ranging in size from "microdots" to "portions of wire 8 millimeters in length," the FDA added.

Most metal fragments were the size of two grains of salt, Perrigo said.

The company said it was is in possession of 100 percent of the batch that originally prompted the investigation.

Perrigo told the FDA about the finding on November 1, said Fred Richman, head of compliance management and operations in a division of the FDA's regulatory affairs office. Perrigo said it informed the agency on November 2.

Perrigo, based in Allegan, Michigan, said the recall was expected to cost $2.9 million.

Its fiscal first-quarter results will now include an after-tax charge of $667,000, or 1 cent a share, because of the recall, reducing its quarterly earnings to 18 cents a share, Perrigo said. It also reaffirmed its earnings outlook.

The company has in the past recalled other products containing acetaminophen, including a children's liquid pain reliever in 2005 because of an unmarked dosing syringe.

In 1999, Perrigo recalled 44,736 bottles of 500-milligram acetaminophen pills from dozens of stores because of mold.

(Additional reporting by Susan Heavey in New York and Ankur Relia in Bangalore)

Scientific American