Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL)...
FDA Recall #D-0174-2021 — Class II — December 9, 2020
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
Reason for Recall
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Recalling Firm
Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
127,392 bottles
Distribution
Nationwide USA and Puerto Rico
Code Information
Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated