Drug product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
D-0011-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 688 50 mL syringes
- Official record key
drug-enforcement:D-0011-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275341, Exp. 10/3/2023; 17-275853, Exp. 10/11/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility