OTC Pain Reliever Recalled Over Labeling Error

A single lot of acetaminophen extra-strength pain reliever/fever reducer tablets is being recalled by LNK International Inc because the product’s label mistakenly states the tablets are enteric coated, according to the July 28, 2021, US Food and Drug Administration (FDA) Enforcement Report.

“The primary label contains the words ‘enteric coated,’” the FDA report explained, “but the tablet is not enteric coated and should only say ‘coated tablet.’”

The recall affects 500-mg acetaminophen extra-strength pain reliever/fever reducer, 50 tablets (NDC 46122-649-71), from lot P120999 (Exp. 7/31/22). The tablets were distributed by Amerisource Bergen in Pennsylvania.

LNK International voluntarily initiated the recall July 7, 2021. The FDA designated the recall Class III on July 16, 2021. Under the recall classification, use of the affected tablets is not likely to cause harm.

Acetaminophen extra-strength pain reliever/fever reducer is an over-the-counter medication used to treat mild to moderate pain and reduce fever.