Morton Grove Pharmaceuticals recalls
FDA enforcement reports naming Morton Grove Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Mar 9, 2022
- Mar 9, 2022Dexamethasone Elixir, USP 0Drug · Morton Grove Pharmaceuticals, Inc.Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.Class II
- Sep 29, 2021Promethazine Syrup Plain, 6Drug · Morton Grove Pharmaceuticals, Inc.CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Class II
- Sep 29, 2021Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufacture…Drug · Morton Grove Pharmaceuticals, Inc.CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Class II
- Sep 29, 2021Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6Drug · Morton Grove Pharmaceuticals, Inc.CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.Class II
- Dec 30, 2020Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl o…Drug · Morton Grove Pharmaceuticals, Inc.Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.Class II
- Oct 16, 2019Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL)…Drug · Morton Grove Pharmaceuticals, Inc.Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14Class II
- Aug 15, 2018Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx on…Drug · Morton Grove Pharmaceuticals, Inc.Defective Container: Tamper Evident foil seal not completely intact.Class II
- Sep 6, 2017Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62Drug · Morton Grove Pharmaceuticals, Inc.Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.Class II
- Jan 27, 2016Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGPDrug · Morton Grove Pharmaceuticals, Inc.Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.Class III