Why it was recalled
Labeling: Not elsewhere classified - count on the label was incorrect.
Product description
Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
Lot numbers, UPCs & expiration codes
Lot # 6050129, Exp 05/31/17
Where it was sold
Virginia
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-0839-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 22, 2016
- FDA report date
- May 11, 2016
- Quantity
- 2730 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- A-S Medication Solutions LLC.
Original FDA data
Every field from FDA enforcement report D-0839-2016, exactly as published.
Show all FDA fields
- City
- Libertyville
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74011
- Address
- 2401 Commerce Dr
- Code information
- Lot # 6050129, Exp 05/31/17
- Postal code
- 60048-4464
- Report date
- May 11, 2016
- Product type
- Drugs
- Recall number
- D-0839-2016
- Classification
- Class III
- Recalling firm
- A-S Medication Solutions LLC.
- Product quantity
- 2730 bottles
- Termination date
- Oct 20, 2016
- Reason for recall
- Labeling: Not elsewhere classified - count on the label was incorrect.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0
- Distribution pattern
- Virginia
- Recall initiation date
- Apr 22, 2016
- Initial firm notification
- Telephone
- Center classification date
- May 5, 2016