Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Recall Number: D-0356-2025
Firm: Somerset Therapeutics Private Limited
Classification: Class II
Status: Ongoing
Report Date: 20250416
Initiation Date: 20250321
Termination Date:
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Product Description
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41