Morton Grove Pharmaceuticals, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 6
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0713-2022 | Class II | Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morto | February 21, 2022 |
| D-0815-2021 | Class II | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate | September 3, 2021 |
| D-0816-2021 | Class II | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockha | September 3, 2021 |
| D-0814-2021 | Class II | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx | September 3, 2021 |
| D-0174-2021 | Class II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bo | December 9, 2020 |
| D-0130-2020 | Class II | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx o | September 23, 2019 |
| D-1042-2018 | Class II | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufact | July 24, 2018 |
| D-1125-2017 | Class II | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when r | August 10, 2017 |
| D-0571-2016 | Class III | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-6 | December 15, 2015 |