D-1057-2023 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
- 1,389 syringes
Product Description
HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1
Reason for Recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 17-270683, Exp 7/18/2023; 17-271119, Exp 7/25/2023; 17-271339, Exp 7/27/2023; 17-272202, Exp 8/10/2023; 17-272241, Exp 8/13/2023; 17-272783, Exp 8/22/2023; 17-273431, Exp 9/3/2023; 17-273615, Exp 9/5/2023