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.
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
Lot numbers, UPCs & expiration codes
Lot: 4138197; Exp 10/31/2025
Where it was sold
Nationwide within the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0631-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 21, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 429 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A-S Medication Solutions LLC
Original FDA data
Every field from FDA enforcement report D-0631-2024, exactly as published.
Show all FDA fields
- City
- Libertyville
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 94873
- Address
- 2401 Commerce Dr
- Code information
- Lot: 4138197; Exp 10/31/2025
- Postal code
- 60048-4464
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0631-2024
- Classification
- Class I
- Recalling firm
- A-S Medication Solutions LLC
- Product quantity
- 429 bottles
- Termination date
- May 7, 2025
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States.
- Recall initiation date
- Jun 21, 2024
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 8, 2024