Drug product
HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
D-0027-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,190 30 mL syringes
- Official record key
drug-enforcement:D-0027-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot:17-275680, Exp. 10/8/2023; 17-275945, Exp. 10/13/2023; 17-276094, Exp. 10/17/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility