Drug product
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
D-0002-2024
Product summary
- Event
- Event 93103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,775 5 mL Syringes
- Official record key
drug-enforcement:D-0002-2024
Official wording
Reason: Lack of assurance of sterility:
Code information: Lot: 17-275224, 17-275225, 17-275233, 17-275235, 17-275253, 17-275259, 17-275263, 17-275267 Exp. 10/2/2023; 17-275340, Exp. 10/3/2023; 17-275512, Exp. 10/5/2023; 17-275633, 17-275657, Exp. 10/8/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility