Product: Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only,  Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
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