Drug product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
D-0029-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,550 30 mL syringes
- Official record key
drug-enforcement:D-0029-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot:17-275315, Exp.10/3/2023; 17-275466, 17-275477, Exp.10/4/2023; 17-276102, Exp. 10/17/2023; 17-276221, Exp. 10/19/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility