Morton Grove, IL, United States
Morton Grove Pharmaceuticals, Inc. recalls
5 recalls recorded since 2018, most recently on 21 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 21 February 2022
- Terminated
- 6 August 2024
- Reason
- Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0713-2022
- 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.
Completed Class II Drugs
- Recall started
- 3 September 2021
- Reason
- CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- Distribution
- Nationwide USA and China
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0815-2021, D-0816-2021, D-0814-2021
- Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Mor
- Valproic Acid Oral Solution USP, (250 mg/5 mL), 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: 604
- 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, Mo
Terminated Class II Drugs
- Recall started
- 9 December 2020
- Terminated
- 24 September 2022
- Reason
- Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0174-2021
- 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, In
Terminated Class II Drugs
- Recall started
- 23 September 2019
- Terminated
- 24 September 2022
- Reason
- Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0130-2020
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
Terminated Class II Drugs
- Recall started
- 24 July 2018
- Terminated
- 9 September 2022
- Reason
- Defective Container: Tamper Evident foil seal not completely intact.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1042-2018
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.