Recalls / Class I
Class ID-0631-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 50090-5313
- FDA application
- M013
- Affected lot / code info
- Lot: 4138197; Exp 10/31/2025
Why it was recalled
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.
Recalling firm
- Firm
- A-S Medication Solutions LLC
- Manufacturer
- A-S Medication Solutions
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 2401 Commerce Dr, Libertyville, Illinois 60048-4464
Distribution
- Quantity
- 429 bottles
- Distribution pattern
- Nationwide within the United States.
Timeline
- Recall initiated
- 2024-06-21
- FDA classified
- 2024-08-08
- Posted by FDA
- 2024-08-14
- Terminated
- 2025-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0631-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.