FDA issues recall for popular painkiller

NILES - More than 120 stores, including Wal-Mart and Meijer, started pulling acetaminophen off their shelves Thursday.

The U.S. Food and Drug Administration (FDA) Thursday alerted the public to a voluntary recall being conducted by Perrigo Co. of Allegan for 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands. The recall was a result of small metal fragments found in a small number of the caplets.

Approximately 11 million bottles containing varying quantities of acetaminophen 500 mg caplets have been affected by this recall. A list of batches affected can be found at http://www.fda.gov/oc/po/ firmrecalls/perrigo/perrigobatchlist.html.

Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall is located on FDA's Web site at http://www.fda.gov/oc/po/firmrecalls/per...list.html.

Niles Super Wal-Mart Store Manager Dennis Carlson said his store pulled bottles of the Equate brand of acetaminophen off the shelves "right away" Thursday, though he did not have a figure of how many.

"It's stopped at our registers and won't let us sell it, period," Carlson said.

Anyone who thinks they may have purchased an affected bottle of acetaminophen from the Niles Wal-Mart should bring the product to the store's pharmacy, Carlson added. And, the FDA recommends consumers who believe they are in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department at (877) 546-0454 for further instructions.

Any adverse reactions experienced with the use of this product should be reported to Perrigo at the above number and the FDA's MedWatch Program by phone at (800) FDA-1088, by fax at (800) FDA-0178 or on the MedWatch Web site at http://www.fda.gov/medwatch.

To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is 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. Consumers should consult their physician if they suspect they've been harmed by use of this product.

FDA is currently investigating the cause of the metal particles found in the acetaminophen 500 mg caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely. The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in 500 mg caplets of acetaminophen. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector, resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from "microdots" to portions of wire 8 mm in length.

At this time FDA does not anticipate this action will cause a shortage of acetaminophen. Currently, only one strength - 500 mg caplets - is affected. Consumers may wish to take additional amounts of the lower strengths of acetaminophen tablets or caplets, which are not affected by this recall, to reach the 500 mg dose or access acetaminophen produced by alternate manufacturers. In all instances, FDA advises consumers to follow labeled instructions for maximum daily dosage.

Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.

Nilesstar.com