MICHIGAN, November, 2006 - Perrigo Co., a major manufacturer of store-brand acetaminophen, recalled 11 million bottles of the pain-relieving pills after discovering some were contaminated with metal fragments.
The recall affects bottles containing various amounts of 500-milligram caplets.
Perrigo Co. bills itself as the world's largest manufacturer of store-brand nonprescription drugs, although they would not disclose the chains for which it manufactures the store-brand acetaminophen.
There were no immediate reports of injuries or illness. The contaminated pills included metal fragments ranging in size from "microdots" to portions of wire one-third of an inch long, the FDA said.
Consumers who take any of the contaminated pills could suffer minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote. Anyone who suspects they have been injured should contact a doctor.
For a list of batches affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html.
Any adverse reactions experienced with the use of this product should be reported to Perrigo toll-free at (877) 546-0454, and the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178 or on the MedWatch website at www.fda.gov/medwatch.
