FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets
The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500mg caplets are affected by this recall. For a list of batches affected, please see 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 website at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.
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.
Consumers who believe they are 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 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 website at www.fda.gov/medwatch.