Home / Recalls / Somerset Therapeutics Private Limited / D-0357-2025

D-0357-2025 Class II Ongoing

Recalled by Somerset Therapeutics Private Limited — Bengaluru, N/A

Recall Details

Product Type
Drugs
Report Date
April 16, 2025
Initiation Date
March 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,960 vials

Product Description

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Distribution Pattern

U.S. Nationwide

Code Information

NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026

Other recalls by Somerset Therapeutics Private Limited

  • D-0358-2025 Class II — Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf (March 21, 2025)
  • D-0356-2025 Class II — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufact (March 21, 2025)
  • D-0354-2025 Class II — Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, (March 21, 2025)
  • D-0355-2025 Class II — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufact (March 21, 2025)