Drug product
fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
D-1043-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,124 syringes
- Official record key
drug-enforcement:D-1043-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270664, Exp. 7/18/2023; 17-270886, Exp. 7/20/2023; 17-270976, 17-270989, Exp. 7/23/2023; 17-271335, Exp. 7/27/2023; 17-271572, Exp. 8/1/2023; 17-271747, Exp. 8/3/2023; 17-271808, Exp. 8/6/2023; 17-272023, Exp. 8/9/2023; 17-272203, Exp. 8/13/2023; 17-272718, Exp. 8/21/2023; 17-272797, Exp. 8/22/2023; 17-273157, Exp. 8/29/2023; 17-273507, Exp. 9/4/2023; 17-273766, Exp. 9/7/2023; 17-273862, Exp. 9/10/2023; 17-274052, Exp. 9/12/2023; 17-274208, Exp. 9/14/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility