Drug product
ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
D-0003-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,590 5 mL Syringes.
- Official record key
drug-enforcement:D-0003-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275252, 17-275276, Exp. 10/2/2023; 17-275525, Exp. 10/5/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility