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-1071-2023
Product summary
- Event
- Event 92752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,994 syringes
- Official record key
drug-enforcement:D-1071-2023
Official wording
Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles
Code information: Lot: 17-274122, 17-274147, 17-274155, 17-274158, 17-274162, Exp. 9/13/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility