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

Recall Number: D-0854-2021

Firm: American Health Packaging

Classification: Class II

Status: Terminated

Report Date: 20211006

Initiation Date: 20210915

Termination Date: 20230608

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

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