Recalls / Class II
Class IID-0816-2021
Product
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
- Affected lot / code info
- Lot #: UV1159
Why it was recalled
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Recalling firm
- Firm
- Morton Grove Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6451 Main St, Morton Grove, Illinois 60053-2633
Distribution
- Quantity
- 38,748 bottles
- Distribution pattern
- Nationwide USA and China
Timeline
- Recall initiated
- 2021-09-03
- FDA classified
- 2021-09-20
- Posted by FDA
- 2021-09-29
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0816-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.