Home / Recalls / Morton Grove Pharmaceuticals, Inc. / D-0174-2021

D-0174-2021 Class II Terminated

Recalled by Morton Grove Pharmaceuticals, Inc. — Morton Grove, IL

Recall Details

Product Type
Drugs
Report Date
December 30, 2020
Initiation Date
December 9, 2020
Termination Date
September 24, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
127,392 bottles

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.

Distribution Pattern

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.

Other recalls by Morton Grove Pharmaceuticals, Inc.

  • D-0713-2022 Class II — Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Ma (February 21, 2022)
  • D-0815-2021 Class II — Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL (September 3, 2021)
  • D-0814-2021 Class II — Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), (September 3, 2021)
  • D-0816-2021 Class II — Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manu (September 3, 2021)
  • D-0130-2020 Class II — Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz ( (September 23, 2019)
  • D-1042-2018 Class II — Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle (July 24, 2018)
  • D-1125-2017 Class II — Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per (August 10, 2017)
  • D-0571-2016 Class III — Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, (December 15, 2015)