November 9, 2006
Better check your medicine cabinet. Perrigo Company of Allegan, Michigan is recalling 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.
Perrigo refused to identify the brand names under which the contaminated caplets wre sold. However, public filings indicate the company makes drugs for Wal-Mart, CVS, Walgreen and Costco, among others.
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 Food and Drug Administration'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 said it 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.
FDA said it is currently investigating the cause of the metal particles found in the acetaminophen 500 mg. caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely.
The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in caplets of acetaminophen, 500 mg.
Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments.
