FDA recall D-0433-2024 · initiated Apr 2, 2024
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.