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
Product summary
- 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
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'