Drug product
HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
D-1057-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,389 syringes
- Official record key
drug-enforcement:D-1057-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-270683, Exp 7/18/2023; 17-271119, Exp 7/25/2023; 17-271339, Exp 7/27/2023; 17-272202, Exp 8/10/2023; 17-272241, Exp 8/13/2023; 17-272783, Exp 8/22/2023; 17-273431, Exp 9/3/2023; 17-273615, Exp 9/5/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility