Drug product
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
D-1062-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,340 syringes
- Official record key
drug-enforcement:D-1062-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270813, Exp. 7/19/2023; 17-271485, Exp. 7/31/2023; 17-271809, Exp. 8/6/2023; 17-272314, Exp. 8/14/2023; 17-272780, Exp. 8/22/2023; 17-273141, Exp. 8/29/2023; 17-273687, Exp. 9/6/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility