Drug product
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
D-1075-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 621 syringes
- Official record key
drug-enforcement:D-1075-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270666, Exp. 7/18/2023; 17-270879, Exp. 7/20/2023; 17-271669, Exp. 8/2/2023; 17-272287, Exp. 8/14/2023; 17-272366, Exp. 8/15/2023; 17-272991, Exp. 8/24/2023; 17-273512, Exp. 9/4/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility