Drug 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

D-0665-2021

July 07, 2021

Class III

Product summary

Firm: LNK International, Inc.
Event: Event 88244
Status: Terminated
Classification: Class III
Quantity: 8,472 bottles
Official record key: drug-enforcement:D-0665-2021

Official wording

Reason: 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'

Code information: Lot # P120999, Exp 07/31/2022

Distribution pattern: Distributed in PA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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'