Drug 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)
D-0357-2025
Product summary
- Event
- Event 96569
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,960 vials
- Official record key
drug-enforcement:D-0357-2025
Official wording
Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
Code information: NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Sterility assurance
Lack of Assurance of Sterility