Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
Recall Number: D-0367-2025
Firm: Amerisource Health Services LLC
Classification: Class II
Status: Ongoing
Report Date: 20250430
Initiation Date: 20250402
Termination Date:
Reason for Recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Product Description
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.