Home / Recalls / Morton Grove Pharmaceuticals, Inc. / D-0814-2021

D-0814-2021 Class II

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

Recall Details

Product Type
Drugs
Report Date
September 29, 2021
Initiation Date
September 3, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
116,400 bottles

Product Description

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 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: 60432-608-16

Reason for Recall

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

Distribution Pattern

Nationwide USA and China

Code Information

Lot #: UV1335; UV1352; and UV1373

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-0816-2021 Class II — Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manu (September 3, 2021)
  • D-0174-2021 Class II — Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) (December 9, 2020)
  • 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)