Drug product
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
D-0506-2024
Product summary
- Event
- Event 94452
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,578 units
- Official record key
drug-enforcement:D-0506-2024
Official wording
Reason: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Code information: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance