Drug product
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
D-1064-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,699 syringes
- Official record key
drug-enforcement:D-1064-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270804, Exp. 7/19/2023; 17-271108, Exp. 7/25/2023; 17-271496, Exp. 7/31/2023; 17-271844, Exp. 8/6/2023; 17-272045, Exp. 8/9/2023; 17-272288, Exp. 8/14/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility