Drug product
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4
D-1080-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,235 syringes
- Official record key
drug-enforcement:D-1080-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-273353, Exp 8/31/2023, 17-270602, Exp 7/17/2023; 17-270706, Exp 7/18/2023; 17-271416, Exp 7/30/2023; 17-272049, Exp 8/9/2023; 17-272277, Exp 8/14/2023; 17-273231, Exp 8/30/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility