FDAClass IIIJuly 28, 2021

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever recall: Labeling Error

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

Why was Acetaminophen EXTRA STRENGTH Pain Reliever / Fever recalled?

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # P120999, Exp 07/31/2022

Product
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Recalling firm
LNK International, Inc.
Quantity
8,472 bottles
Distribution
Distributed in PA
Recall date
July 28, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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