ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets recalled over labeling errors

Recall date

September 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medline Industries Inc recalls ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc.,…

Recall number

D-0662-2016

FDA classification

Class I

Brand / firm

Medline Industries Inc

Sold / distributed

Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.