Recalls / Class III
Class IIID-0839-2016
Product
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
- Affected lot / code info
- Lot # 6050129, Exp 05/31/17
Why it was recalled
Labeling: Not elsewhere classified - count on the label was incorrect.
Recalling firm
- Firm
- A-S Medication Solutions LLC.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2401 Commerce Dr, Libertyville, Illinois 60048-4464
Distribution
- Quantity
- 2730 bottles
- Distribution pattern
- Virginia
Timeline
- Recall initiated
- 2016-04-22
- FDA classified
- 2016-05-05
- Posted by FDA
- 2016-05-11
- Terminated
- 2016-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0839-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.