Drug product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
D-0356-2025
Product summary
- Event
- Event 96569
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4956 vials
- Official record key
drug-enforcement:D-0356-2025
Official wording
Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
Code information: A240467B, exp. date 07/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Sterility assurance
Lack of Assurance of Sterility