Product: 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.
Reason for recall: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated: 20250402
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated