Those caplets are over-the-counter drugs for pain relief and fever reduction. They're sold by about 130 companies, including Wal-Mart, CVS, and other drug stores, grocery stores, and wholesalers.
The recall is due to "small metal fragments found in a small number of these caplets," states an FDA news release.
The fragments range in size from "microdots" to 8-millimeter pieces of wire, according to the FDA.
The FDA and the caplets' maker, Perrigo Company of Allegan, Mich., are investigating how those metal fragments got into the caplets.
So far, no illnesses, injuries, or consumer complaints have been reported to the FDA or Perrigo, according to the FDA.
The FDA "believes the probability of serious adverse health consequences is remote," the FDA's Jason Brodsky told reporters in a teleconference.
Brodsky is the FDA's assistant commissioner for external relations.
"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," Brodsky says.
Advice for Consumers
For a full list of the companies that sell store-brand 500 milligram acetaminophen made by Perrigo, visit the FDA's web site at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.
The FDA's web site also lists the recalled batches of the drug. That list is posted at www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html.
The recalled drugs have expiration dates ranging from September 2006 through August 2009.
The FDA advises consumers who believe they have the recalled acetaminophen to "discontinue use immediately" and call Perrigo's consumer affairs department at (877) 546-0454 for further instructions.
People who think they may have been harmed by the affected caplets should talk to their doctors, says Brodsky.
"We believe, at present, that this is a relatively small fraction of the total available acetaminophen on the market," the FDA's Douglas Throckmorton, MD, told reporters in the teleconference. Throckmorton is the deputy director of the FDA's Center for Drug Evaluation and Research.
Any adverse reactions to the products should be reported to the FDA's MedWatch program, which can be reached by phone at (800) FDA-1088, by fax at (800) FDA-0178, or on the MedWatch web site at www.fda.gov/medwatch.
Adverse reactions should also be reported by phone to Perrigo's consumer affairs department at (877) 546-0454, says the FDA.
Investigation Under Way
According to the FDA, Perrigo told the FDA about the problem on Nov. 1.
Perrigo discovered, through its own regulatory quality-control procedures, that their tableting equipment was wearing down prematurely, says the FDA.
The FDA says Perrigo told the FDA that 70 million caplets went through a metal detector, resulting in the discovery of about 200 caplets containing metal fragments ranging from "microdots" to portions of wire 8 millimeters long.
Perrigo is working with the FDA on correcting the problem.
In a Perrigo news release, the company says it bought raw materials for the caplets from a third-party supplier. Perrigo didn't name that supplier.
John Hendrickson, Perrigo's executive vice president and general manager of Perrigo Consumer Health Care, commented on the recall in Perrigo's news release.
"Our quality control systems noted trace amounts of metal particulate in a very small number of these caplet products," Hendrickson says.
"Although the frequency of occurrence is very low, the probability of health risk is remote, and there have been no reports of injuries or illness related to this incident, we are taking this measure to maintain the highest possible product quality standards for our retail customers and their store brand consumers."
source - WebMD