Drug product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
D-1050-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 848 bags
- Official record key
drug-enforcement:D-1050-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270533, Exp. 7/16/2023; 17-270580, 17-270581, Exp. 7/17/2023; 17-270654, Exp. 7/18/2023; 17-271044, Exp. 7/24/2023; 17-271243, Exp. 7/26/2023; 17-271439, Exp. 7/30/2023; 17-271562, Exp. 8/1/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility