Morton Grove Pharmaceuticals recalls
Morton Grove Pharmaceuticals appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2022-03-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2016-01-27 to 2022-03-09 |
| By agency | FDA Drug (9) |
| By classification | Class II (8), Class III (1) |
| By status | terminated (6), completed (3) |
| Distribution named in notices | US |
Recalls
- Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton G…
FDA Drug · Class II · 2022-03-09 · Morton Grove Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. - Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only,…
FDA Drug · Class II · 2021-09-29 · Morton Grove Pharmaceuticals
Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. - Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA,…
FDA Drug · Class II · 2021-09-29 · Morton Grove Pharmaceuticals
Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. - Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054
FDA Drug · Class II · 2021-09-29 · Morton Grove Pharmaceuticals
Reason: CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. - 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…
FDA Drug · Class II · 2020-12-30 · Morton Grove Pharmaceuticals
Reason: Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities. - Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharm…
FDA Drug · Class II · 2019-10-16 · Morton Grove Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 - Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, I…
FDA Drug · Class II · 2018-08-15 · Morton Grove Pharmaceuticals
Reason: Defective Container: Tamper Evident foil seal not completely intact. - Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufact…
FDA Drug · Class II · 2017-09-06 · Morton Grove Pharmaceuticals
Reason: Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product. - Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
FDA Drug · Class III · 2016-01-27 · Morton Grove Pharmaceuticals
Reason: Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.