PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 24, 2016 Initiated: September 25, 2015 #D-0662-2016

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Medline Industries Inc
Units Affected
7,372 HDPE Bottles
Distribution
Nationwide
Location
Mundelein, IL

Frequently Asked Questions

What product 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.. Recalled by Medline Industries Inc. Units affected: 7,372 HDPE Bottles.
Why was this product recalled?
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 24, 2016. Severity: Critical. Recall number: D-0662-2016.