Drug product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
D-1070-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,114 bags
- Official record key
drug-enforcement:D-1070-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-274485, Exp. 9/19/2023; 17-270783, Exp. 7/19/2023; 17-270882, Exp. 7/20/2023; 17-271430, Exp. 7/30/2023; 17-271509, Exp. 7/31/2023; 17-272224, 17-272238, Exp. 8/13/2023; 17-272704, Exp. 8/21/2023; 17-273147, Exp. 8/29/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility