Drug product
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
D-1042-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,197 syringes
- Official record key
drug-enforcement:D-1042-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-271144, Exp. 7/25/2023; 17-271354, Exp. 7/27/2023; 17-271681, Exp. 8/2/2023; 17-271990, Exp. 8/7/2023; 17-272457, Exp. 8/16/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility