Home / Recalls / Morton Grove Pharmaceuticals, Inc. / D-0713-2022

D-0713-2022 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
March 9, 2022
Initiation Date
February 21, 2022
Termination Date
August 6, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.

Reason for Recall

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23

Other recalls by Morton Grove Pharmaceuticals, Inc.

  • 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-0814-2021 Class II — Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), (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)