Drug product
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
D-1054-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,082 syringes
- Official record key
drug-enforcement:D-1054-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-271133, 17-271155, Exp. 7/25/2023; 17-271568, 17-271569, Exp. 8/1/2023; 17-271741, 17-271762, Exp. 8/3/2023; 17-272051, Exp. 8/9/2023; 17-272227, Exp. 8/13/2023; 17-272343, Exp. 8/15/2023; 17-272799, Exp. 8/22/2023; 17-273173, Exp. 8/29/2023; 17-273495, Exp. 9/4/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility