Drug product
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
D-1068-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 723 syringes
- Official record key
drug-enforcement:D-1068-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-271060, Exp. 7/24/2023; 17-271252, Exp. 7/26/2023; 17-271571, Exp. 8/1/2023; 17-272471, Exp. 8/16/2023; 17-272785, Exp. 8/22/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility