The Food and Drug Administration (FDA) in the U.S. has alerted consumers that a drug company in Michigan has recalled millions of bottles of a commonly used painkiller because the pills may contain pieces of metal.
Drug Company Perrigo voluntarily recalled 383 lots of 500 mg acetaminophen caplets after discovering that some of the bottles have been contaminated and contain metal pieces as large as 8 millimeters in length.
Acetaminophen belongs to a class of drugs called analgesics (pain relievers) and antipyretics (fever reducers).
The FDA says as yet it has received no reports of injuries or illnesses related to the contamination, and no consumer complaints have been reported to the FDA or to Perrigo.
But Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research says there is a concern that if the metal pieces were swallowed it could cause throat or stomach injuries.
Throckmorton says that presents the remote possibility of serious adverse consequences.
The FDA along with the company is investigating how the metal particles came to be in the acetaminophen pills after Perrigo discovered through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely.
The presence of the metal fragments in caplets of acetaminophen were discovered when the pills were passed through a metal detector and approximately 200 caplets were found to contain metal fragments ranging in size from "microdots" to portions of wire 8 mm in length.
The Nationwide recall of 500mg Strength Store-Brand Acetaminophen Caplets involves 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands in approximately 11 million bottles of acetaminophen.
Acetaminophen is the same active ingredient contained in Tylenol but the FDA says the recall involves only store brands and does not include Tylenol products.
The FDA says many stores may have already received lots of the compromised caplets, including Wal Mart, CVS, PathMark, Winn Dixie and Kmart.
The FDA has released a list of affected lot numbers and encouraged consumers to check numbers on their acetaminophen products to see if they match.
Consumers should consult their physician if they suspect they have been harmed by use of this product.
Sabotage or intentional adulteration is not suspected at this stage and it appears that many of the affected lots have been on the market for up three years or more.
FDA officials advise consumers to check www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html in order to determine if they are in possession of a recalled product by locating the batch number printed on the container label.