Drug product
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
D-1072-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 896 bags
- Official record key
drug-enforcement:D-1072-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270540, Exp. 7/16/2023; 17-270663, Exp. 7/18/2023; 17-271059, Exp. 7/24/2023; 17-271249, Exp. 7/26/2023; 17-271593, Exp. 8/1/2023; 17-271742, Exp. 8/3/2023; 17-272064, Exp. 8/9/2023; 17-272106, Exp. 8/10/2023; 17-272279, Exp. 8/14/2023; 17-272530, Exp. 8/17/2023; 17-272603, Exp. 8/20/2023; 17-272776, Exp. 8/22/2023; 17-273075, Exp. 8/28/2023; 17-273344, Exp. 8/31/2023; 17-273409, Exp. 9/3/2023; 17-274221, 17-274222, Exp. 9/14/2023; 17-274414, Exp. 9/18/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility