D-0631-2024 Class I Terminated
FDA drug recall D-0631-2024 was initiated by A-S Medication Solutions LLC on June 21, 2024 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated May 7, 2025). Affected quantity: 429 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 14, 2024
- Initiation Date
- June 21, 2024
- Termination Date
- May 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 429 bottles
Product Description
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Reason for Recall
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.
Distribution Pattern
Nationwide within the United States.
Code Information
Lot: 4138197; Exp 10/31/2025