Drug product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
D-0015-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 895 50 mL syringes
- Official record key
drug-enforcement:D-0015-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275165, 17-275166, Exp. 10/1/2023; 17-275217, Exp. 10/2/2023; 17-275715, Exp. 10/9/2023; 17-276035, Exp. 10/16/2023; 17-276112, Exp. 10/17/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility