Perrigo, a large manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand market, said Thursday it is voluntarily recalling some of its store-brand Acetaminophen 500 mg caplets on a nationwide basis because of trace amounts of metal in some of the caplets.
The Food & Drug Administration is investigating the source of the metal fragments. Perrigo initiated the recall after noticing that its equipment had been wearing down prematurely during quality control procedures. The metal fragments range from “microdots” to wire pieces 8mm long, and have been found in only the 500mg caplets. Lower dose caplets have not been affected by the recall.
"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," said John Hendrickson, EVP and General Manager of Perrigo Consumer Healthcare.
Perrigo is informing distributors and retailers about the recall, which affects 383 batches, and has outlined steps it will take to facilitate product replacement. Questions or concerns about the product should be directed to Perrigo's Consumer Affairs Department, toll free, 877-546-0454. Any adverse reactions experienced with the use of this product should also be reported to the FDA MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178 or on the MedWatch website at http://www.fda.gov/medwatch.
The total cost of the recall for sales returns, handling of on-hand inventories and disposal is estimated to be $2.9 million, and discussions are on-going with the raw material supplier to determine the extent to which the recall-related costs may be recoverable.
The FDA said consumers can check if their product is affected by the recall by comparing the batch number, which is printed on the container label, to the list available from the FDA at http://www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html.
A list of stores that potentially carry the recalled products can be found at http://www.fda.gov/oc/po/firmrecalls/perrigo/perrigocuslist.html.
No illness or injuries have been reported to either the FDA of Perrigo thus far as a result of the metal fragments. Consumers may experience minor stomach discomfort or cuts to the throat or mouth, but at this time the FDA says that the potential for serious health problems stemming from the caplets is “remote.”
According to the FDA, Perrigo is in the process of notifying distributors and retailers and will decide on the steps it will take to replace the products.
Perrigo did not immediately return a call for comment.