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: 71286-2071-1
D-1079-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,770 syringes
- Official record key
drug-enforcement:D-1079-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270539, Exp. 7/16/2023; 17-270981, Exp. 7/23/2023; 17-271167, Exp. 7/25/2023; 17-271337, Exp. 7/27/2023; 17-271827, Exp. 8/6/2023; 17-272214, Exp. 8/13/2023; 17-272536, 17-272555, Exp. 8/17/2023; 17-273424, 17-273432, Exp. 9/3/2023; 17-273476, Exp. 9/4/2023; 17-273882, Exp. 9/10/2023; 17-274044, Exp. 9/12/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility