Morton Grove Pharmaceuticals, Inc. Recalls

All product recalls associated with Morton Grove Pharmaceuticals, Inc..

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Recall Summary

Total Recalls

9

Past Year

0

Class I (Serious)

0

Most Recent

Feb 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Dexamethasone Elixir (Morton Grove) – Unknown Impurity Levels (2022)

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

Class IIModerate

FDAFeb 21, 2022Nationwide• Morton Grove Pharmaceuticals, Inc.

Valproic Acid Oral Solution (Morton Grove) – Microbial Risk (2021)

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

Class IIModerate

FDASep 3, 2021Nationwide• Morton Grove Pharmaceuticals, Inc.

Promethazine Syrup (Morton Grove) – Microbial Risk (2021)

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

Class IIModerate

FDASep 3, 2021Nationwide• Morton Grove Pharmaceuticals, Inc.

Promethazine With Codeine Syrup (Morton Grove) – Microbial Risk (2021)

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

Class IIModerate

FDASep 3, 2021Nationwide• Morton Grove Pharmaceuticals, Inc.

Hydroxyzine HCl Solution (Morton Grove) – impurity specs (2020)

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

Class IIModerate

FDADec 9, 2020Nationwide• Morton Grove Pharmaceuticals, Inc.

Prednisolone Oral Solution (Morton Grove) – impurity issue (2019)

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Class IIModerate

FDASep 23, 2019Nationwide• Morton Grove Pharmaceuticals, Inc.

Prednisolone Oral Solution (Morton Grove) – defective seal (2018)

Defective Container: Tamper Evident foil seal not completely intact.

Class IIModerate

FDAJul 24, 2018Nationwide• Morton Grove Pharmaceuticals, Inc.

Amoxicillin/Clavulanate Suspension (Morton Grove) – foreign material (2017)

Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.

Class IIModerate

FDAAug 10, 2017Nationwide• Morton Grove Pharmaceuticals, Inc.

Lindane Lotion (Morton Grove Pharmaceuticals) – Out of Specification (2015)

Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.

Class IIILow

FDADec 15, 2015Nationwide• Morton Grove Pharmaceuticals, Inc.

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Morton Grove Pharmaceuticals, Inc. Recalls

Recall Summary

Dexamethasone Elixir (Morton Grove) – Unknown Impurity Levels (2022)

Valproic Acid Oral Solution (Morton Grove) – Microbial Risk (2021)

Promethazine Syrup (Morton Grove) – Microbial Risk (2021)

Promethazine With Codeine Syrup (Morton Grove) – Microbial Risk (2021)

Hydroxyzine HCl Solution (Morton Grove) – impurity specs (2020)

Prednisolone Oral Solution (Morton Grove) – impurity issue (2019)

Prednisolone Oral Solution (Morton Grove) – defective seal (2018)

Amoxicillin/Clavulanate Suspension (Morton Grove) – foreign material (2017)

Lindane Lotion (Morton Grove Pharmaceuticals) – Out of Specification (2015)