Drug product
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
D-0374-2025
Product summary
- Event
- Event 96607
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,655 syringes
- Official record key
drug-enforcement:D-0374-2025
Official wording
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Code information: Lot #:2530023, Exp.: 7/12/2025
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility