FDA Recall D-0631-2024
A-S Medication Solutions LLC · Libertyville, IL
Class I — life-threatening Terminated 320 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0631-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide within the United States.
- Recall initiated
- 2024-06-21
- Classified by FDA Center
- 2024-08-08
- FDA published
- 2024-08-14
- Terminated
- 2025-05-07
- Recalling firm
- A-S Medication Solutions LLC
- Firm location
- Libertyville, IL
Drug identification
- Brand name(s)
- ACETAMINOPHEN
- Generic name(s)
- ACETAMINOPHEN
- Manufacturer(s)
- A-S Medication Solutions
- NDC(s)
50090-5313- Route(s)
- ORAL