Drug product
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 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 68001-581-41.
D-0368-2025
Product summary
- Event
- Event 96636
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,189 vials
- Official record key
drug-enforcement:D-0368-2025
Official wording
Reason: Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Code information: A240482A, EXP 08/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Bacterial contamination
-
Sterility assurance
Lack of assurance of sterility