Drug product
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
D-0373-2025
Product summary
- Event
- Event 96607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,830 syringes
- Official record key
drug-enforcement:D-0373-2025
Official wording
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Code information: Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility