The U.S. Food and Drug Administration (FDA) recently alerted the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan, for 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store brands. Metal fragments ranging in size from “microdots” to portions of wire 8 mm in length were found in about 200 caplets after 70 million caplets were passed through a metal detector. FDA is currently investigating the cause of the metal particles, but Perrigo originally informed FDA of the problem after discovering through its own regulatory quality control procedures that its tableting equipment was wearing down prematurely.
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Approximately 11 million bottles containing varying quantities of acetaminophen 500 mg caplets are affected by the recall. To date, no related illness or injuries have been reported and no consumer complaints have been received by the FDA or Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however, swallowing an affected caplet 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 can determine whether they have a recalled product by locating the batch number printed on the container label. For a list of batches affected, visit www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. A list of stores that carry store brands potentially affected by this recall is located on FDA’s Web site at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.
According to a recent statement, FDA does not anticipate that this action will cause a shortage of acetaminophen.