Recalls / Class III
Class IIID-0665-2021
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
- Affected lot / code info
- Lot # P120999, Exp 07/31/2022
Why it was 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'
Recalling firm
- Firm
- LNK International, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Arkay Dr, N/A, Hauppauge, New York 11788-3707
Distribution
- Quantity
- 8,472 bottles
- Distribution pattern
- Distributed in PA
Timeline
- Recall initiated
- 2021-07-07
- FDA classified
- 2021-07-16
- Posted by FDA
- 2021-07-28
- Terminated
- 2023-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0665-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.