Drug product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
D-1067-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,486 syringes
- Official record key
drug-enforcement:D-1067-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270811, Exp. 7/19/2023; 17-270954, 17-270983, Exp. 7/23/2023; 17-271231, Exp. 7/26/2023; 17-271690, Exp. 8/2/2023; 17-272204, Exp. 8/13/2023; 17-272684, Exp. 8/20/2023; 17-272992, Exp. 8/24/2023; 17-273053, Exp. 8/28/2023; 17-273436, Exp. 9/3/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility