Drug product
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
D-0631-2024
Product summary
- Event
- Event 94873
- Status
- Terminated
- Classification
- Class I
- Quantity
- 429 bottles
- Official record key
drug-enforcement:D-0631-2024
Official wording
Reason: Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Code information: Lot: 4138197; Exp 10/31/2025
Distribution pattern: Nationwide within the United States.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up