SOMERSET THERAPEUTICS LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0238-2026 | Class III | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per car | November 26, 2025 |
| D-0236-2026 | Class III | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, | November 26, 2025 |
| D-0237-2026 | Class III | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, | November 26, 2025 |
| D-0169-2025 | Class III | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Ther | December 16, 2024 |
| D-0506-2024 | Class II | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) an | April 24, 2024 |
| D-1373-2020 | Class III | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Thera | June 4, 2020 |
| D-1375-2020 | Class III | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Ther | June 4, 2020 |
| D-1374-2020 | Class III | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Ther | June 4, 2020 |