Drug product
HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
D-0028-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,190 50 mL syringes
- Official record key
drug-enforcement:D-0028-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot:17-275728, Exp. 10/9/2023; 17-275791, 17-275803, Exp. 10/10/2023; 17-276244, Exp. 10/20/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility