December 2020 FDA Recall Drug by Morton Grove Pharmaceuticals, Inc.
D-0174-2021 - Failed Impurities/Degradation Specification

This Class II drug recall was voluntarily initiated by Morton Grove Pharmaceuticals, Inc. on December 9, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0174-2021

Reason for Recall
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Initiated
12-09-2020
Reported
12-30-2020
Quantity
127,392 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86904
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Morton Grove Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2022
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.