Drug product
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
D-0020-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 174, 5 mL syringes.
- Official record key
drug-enforcement:D-0020-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot:17-275479, Exp. 10/4/2023; 17-275852, Exp. 10/11/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility