Valproic Acid Oral Solution USP recalled over manufacturing violations
- Recall date
- September 3, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Morton Grove Pharmaceuticals, Inc. recalls Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsipp…
- Recall number
- D-0816-2021
- FDA classification
- Class II
- Brand / firm
- Morton Grove Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide USA and China
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, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
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