THURSDAY, Nov. 9, 2006 (HealthDay News) -- A major manufacturer of generic nonprescription drugs sold to top retailers is recalling 11 million bottles of acetaminophen caplets because of possible contamination with metal fragments.
U.S. Food and Drug Administration officials said Thursday there have been no reports of illness or injuries as a result of the recall, issued by Perrigo Co., of Allegan, Mich. The company supplies health-care products to such retailers as Wal-Mart, CVS, Walgreen and Costco.
The recall involves only 500-milligram caplets of the drug sold under store-brand names, so the FDA suggested that consumers who need to take acetaminophen could take additional amounts of lower strengths of the drug.
Acetaminophen is manufactured and distributed under various store brand names. It's best known by the brand name Tylenol, which is made by McNeil Consumer Healthcare.
The recall does not affect any Tylenol products, according to the FDA. And a spokesman for McNeil Consumer Healthcare added that the company "does not produce any products marketed under store brands or private labels."
Perrigo first informed the FDA of the recall on Nov. 1, according to Fred Richman, director of the FDA's division of compliance management and operations, office of enforcement, and office of regulatory affairs.
"Some time elapsed, but the investigation by the firm and the FDA was continuing, and when we had the information and were able to bring it to you, this is the day we're doing it," Richman said during a news conference Thursday morning.
"We believe that this is a small number of lots," added Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "Based on what we understand, there's a remote likelihood of serious adverse consequences."
He added, "If consumers believe they have swallowed an affected caplet, they would have minor chance of serious consequences. Should the consumer believe they are in possession of this acetaminophen product, they should contact the sponsor."
People who swallow an affected caplet could have minor stomach discomfort and/or cuts to the mouth or throat, the FDA said. Consumers should call their doctor if they suspect they have swallowed a contaminated product.
A company investigation turned up metal fragments in roughly 200 pills, after 70 million caplets were passed through a metal detector, the FDA said.
The fragments were apparently the result of manufacturing equipment that was wearing down prematurely, the FDA said. The fragments ranged in size from "microdots" to pieces of actual wire one-third of an inch long.
One trauma expert noted the wire pieces were unlikely to cause serious damage.
"The two biggest things are that you can either cause obstruction or minor bleeding, but these are not life-threatening," said Dr. Maurizio Miglietta, chief of trauma and critical care at New York University School of Medicine/Bellevue Hospital in New York City.
Another expert agreed.
"Everything I've heard so far makes me think that this is very low risk for everybody," said Dr. Carl Ramsay, vice chairman and medical director of emergency medicine at Maimonides Medical Center, in New York City. One possible, but unlikely, scenario would be if metal fragments turned up in an X-ray.
"Physicians need to make sure they know about this, so they don't get thrown off track," Ramsay said. The other, even more unlikely, scenario would be if someone went to get an MRI after ingesting metal-tainted acetaminophen, he added. "MRIs are magnets, and they will try and pull that piece of metal out, so that would be a problem," he explained.
Consumers who think they're in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department (877-546-0454) for further instructions.
Any adverse reactions experienced with the use of the product should be reported to Perrigo at the same phone number and to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or on the MedWatch Web site at www.fda.gov/medwatch.
The recall is considered a Class II recall because the products may cause temporary or "medically reversible" health problems, or because the probability of serious health problems is remote, the FDA said.
The agency added that it did not anticipate a shortage of acetaminophen because of the recall.
According to the FDA, in 2005, Perrigo voluntarily recalled all lots of concentrated infants' drops of a product containing acetaminophen that was packaged with a dosing syringe that might have caused confusion in determining the proper dose for children under 2.
And in 2001, the company recalled 7,788 four-ounce bottles of cherry-flavored pain reliever suspension liquid because the product may have contained more acetaminophen than was indicated on the label.
According to Perrigo's Web site, the company is the world's largest manufacturer of over-the-counter pharmaceutical and nutritional products for food, drug, mass merchandise, dollar store and club-store retailers under their own labels.
More information
To more specifics on the stores and affected batch numbers, visit the FDA.
