Morton Grove Pharmaceuticals, Inc.: Drug Recall

Recall #D-0816-2021 · 09/03/2021

Class II: Risk

Recall Details

Recall Number: D-0816-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Morton Grove Pharmaceuticals, Inc.
Status: Completed
Date Initiated: 09/03/2021
Location: Morton Grove, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 38,748 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide USA and China

Other Recalls by Morton Grove Pharmaceuticals, Inc.

Class II: Risk 02/21/2022

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II: Risk 09/03/2021

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II: Risk 09/03/2021

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II: Risk 12/09/2020

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

View all recalls by Morton Grove Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.