Drug product
fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
D-0014-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 403 bags
- Official record key
drug-enforcement:D-0014-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275517, Exp. 10/5/2023; 17-275862, Exp. 10/11/2023; 17-275980, Exp. 10/15/2023; 17-276036, Exp. 10/16/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility