Drug product
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
D-0854-2021
Product summary
- Event
- Event 88696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 548 ccases
- Official record key
drug-enforcement:D-0854-2021
Official wording
Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Code information: Lot 1000082; Exp 06/30/2022
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations