Drug product
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
D-1063-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,044 bags
- Official record key
drug-enforcement:D-1063-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-271115, Exp. 7/25/2023; 17-271398, Exp. 7/30/2023; 17-272278, Exp. 8/14/2023; 17-272449, Exp. 8/16/2023; 17-272521, Exp. 8/17/2023; 17-272900, Exp. 8/23/2023; 17-273146, Exp. 8/29/2023; 17-273236, Exp. 8/30/2023; 17-273404, Exp. 9/3/2023; 17-273678, Exp. 9/6/2023; 17-273954, Exp. 9/11/2023; 17-274213, Exp. 9/14/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility