Home / Recalls / Somerset Therapeutics Private Limited / D-0355-2025

D-0355-2025 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
997 vials

Product Description

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Distribution Pattern

U.S. Nationwide

Code Information

NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026

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-0357-2025 Class II — Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufac (March 21, 2025)