Drug 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.
D-0367-2025
Product summary
- Event
- Event 96636
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,110 vials
- Official record key
drug-enforcement:D-0367-2025
Official wording
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Code information: A240467B, EXP 07/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Bacterial contamination
-
Sterility assurance
Lack of assurance of sterility