A spokesperson for Perrigo, a large manufacturer of over-the-counter pharmaceutical and nutritional products for the store brand market, said Friday that the company had traced the source of the metal fragments found in some of its 500mg Acetaminophen caplets back to a third party supplier of raw materials. The Food & Drug Administration is continuing its investigating into the source of the metal fragments.
According to the FDA, 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.
Art Shannon, vice president, Investor Relations and Communication at Perrigo, said Perrigo first noticed the problem in late October during quality control screenings in which the pills were passed through a metal detector. Approximately one in 400,000 caplets had traces of metal particulate. The company traced the source of the metal pieces back to a third party supplier of raw materials whose name cannot be released at this time. The FDA is investigating the origin of the metal pieces. Shannon refutes the FDA account that Perrigo had had problems with its machinery.
Perrigo said it informed the FDA of the problem on November 2, and issued a voluntary recall yesterday. Neither Perrigo nor the FDA anticipate any potential health risks as a result of the metal pieces and 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.”
"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 11 million bottles, 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 https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
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.