Somerset Therapeutics Private Limited: Drug Recall

Recall #D-0357-2025 · 03/21/2025

Class II: Risk

Recall Details

Recall Number: D-0357-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Somerset Therapeutics Private Limited
Status: Ongoing
Date Initiated: 03/21/2025
Location: Bengaluru, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,960 vials

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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)

Distribution Pattern

U.S. Nationwide

Other Recalls by Somerset Therapeutics Private Limited

Class II: Risk 03/21/2025

Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II: Risk 03/21/2025

Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II: Risk 03/21/2025

Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II: Risk 03/21/2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

View all recalls by Somerset Therapeutics Private Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.