Drug product
PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
D-0005-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,384 10 mL syringes
- Official record key
drug-enforcement:D-0005-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275231, 17-275232, Exp. 10/2/2023; 17-275563, 17-275567, 17-275573, 17-275580, Exp. 10/8/2023; 17-275767, 17-275784, Exp. 10/10/2023;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility