Drug 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
D-0839-2016
Product summary
- Event
- Event 74011
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2730 bottles
- Official record key
drug-enforcement:D-0839-2016
Official wording
Reason: Labeling: Not elsewhere classified - count on the label was incorrect.
Code information: Lot # 6050129, Exp 05/31/17
Distribution pattern: Virginia
Derived failure modes
-
Labeling or packaging
label was incorrect