FDA-Drug2016-02-24Class I

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

Medline Industries Inc
Hazard

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

Sold states
Nationwide
Affected count
7,372 HDPE Bottles
Manufactured in
1 Medline Pl, Mundelein, IL, United States
Products
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2016

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