Morton Grove Pharmaceuticals, Inc.: Drug Recall

Recall #D-0174-2021 · 12/09/2020

Class II: Risk

Recall Details

Recall Number: D-0174-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Morton Grove Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 12/09/2020
Location: Morton Grove, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 127,392 bottles

Reason for Recall

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

Product Description

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

Distribution Pattern

Nationwide USA and Puerto Rico

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 09/03/2021

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

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.