Product: 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)
Reason for recall: Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiated: 20250321
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated