Valproic Acid Oral Solution recalled over manufacturing violations

Recall date

September 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

American Health Packaging recalls Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by…

Recall number

D-0854-2021

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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