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

Recall Number: D-0816-2021

Firm: Morton Grove Pharmaceuticals, Inc.

Classification: Class II

Status: Completed

Report Date: 20210929

Initiation Date: 20210903

Termination Date:

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

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