Drug product
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
D-0371-2025
Product summary
- Event
- Event 96607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23,610 syringes
- Official record key
drug-enforcement:D-0371-2025
Official wording
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Code information: Lot #: 2431276A, Exp.: 4/20/2025
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility