Drug product
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
D-0355-2025
Product summary
- Event
- Event 96569
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 997 vials
- Official record key
drug-enforcement:D-0355-2025
Official wording
Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
Code information: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Sterility assurance
Lack of Assurance of Sterility