Drug product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
D-1047-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,216 syringes
- Official record key
drug-enforcement:D-1047-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270771, Exp. 7/19/2023; 17-271134, Exp. 7/25/2023; 17-271577, Exp. 8/1/2023; 17-271745, Exp. 8/3/2023; 17-272026, Exp. 8/9/2023; 17-272345, Exp. 8/15/2023; 17-272615, Exp. 8/20/2023; 17-273668, Exp. 9/6/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility