Somerset Therapeutics Private Limited

FDA Regulatory Profile

Somerset Therapeutics Private Limited appears in FDA public data with 5 recalls, 0 510(k) clearances, 10 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0356-2025, Class II) was initiated on March 21, 2025.

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
10
Compliance Actions
3

Recent Recalls

NumberClassProductDate
D-0356-2025Class IIHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset ThMarch 21, 2025
D-0358-2025Class IIHaloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: SomerseMarch 21, 2025
D-0354-2025Class IIMethocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, ManufactureMarch 21, 2025
D-0355-2025Class IIHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset TMarch 21, 2025
D-0357-2025Class IIHaloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset TMarch 21, 2025