Somerset Therapeutics Private Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 10
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0358-2025 | Class II | Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerse | March 21, 2025 |
| D-0356-2025 | Class II | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Th | March 21, 2025 |
| D-0354-2025 | Class II | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufacture | March 21, 2025 |
| D-0355-2025 | Class II | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset T | March 21, 2025 |
| D-0357-2025 | Class II | Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset T | March 21, 2025 |