Drug product
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
D-0006-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,081 syringes
- Official record key
drug-enforcement:D-0006-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275323, 17-275345, Exp. 10/3/2023; 17-275642, 17-275643, 17-275671, Exp. 10/8/2023; 17-275675, 17-275677, Exp. 10/9/2023; 17-276188, Exp. 10/18/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility