D-0665-2021 Class III Terminated
FDA drug recall D-0665-2021 was initiated by LNK International, Inc. on Jul 7, 2021 and is designated Class III. Reason for recall: 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' The recall status is terminated (terminated May 4, 2023). Affected quantity: 8,472 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 28, 2021
- Initiation Date
- Jul 7, 2021
- Termination Date
- May 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,472 bottles
Product Description
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
Reason for Recall
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'
Distribution Pattern
Distributed in PA
Code Information
Lot # P120999, Exp 07/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0665-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026