D-1071-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 17, 2023
- Termination Date
- March 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,994 syringes
Product Description
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
Reason for Recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 17-274122, 17-274147, 17-274155, 17-274158, 17-274162, Exp. 9/13/2023