Drug product
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
D-1049-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,228 syringes
- Official record key
drug-enforcement:D-1049-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270675, 17-270683, Exp. 7/18/2023; 17-271147, 17-271119, Exp. 7/25/2023; 17-271339, Exp. 7/27/2023; 17-271679, Exp. 8/2/2023; 17-272202, Exp. 8/10/2023; 17-272241, Exp. 8/13/2023; 17-272375, Exp. 8/15/2023; 17-272783, Exp. 8/22/2023; 17-273438, 17-273431, Exp. 9/3/2023; 17-273615, Exp. 9/5/2023; 17-273789, 9/7/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility