Drug product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
D-0017-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 190 250 mL bags
- Official record key
drug-enforcement:D-0017-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275974, 17-275979, Exp. 10/15/2023; 17-276110, Exp. 10/17/2023; 17-276234, Exp. 10/19/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility