Drug product
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
D-0013-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,792 bags
- Official record key
drug-enforcement:D-0013-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275164, exp. 10/1/2023; 17-275623, 17-275631, 17-275640, 17-275649,17-275650, 17-275655, 17-275660, Exp. 10/8/2023; 17-275712, 17-275713, 17-275721, 17-275723, 17-275727, Exp. 10/9/2023; 17-276232, Exp. 10/19/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility