EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Recall Number: D-0539-2025

Firm: Mckesson Medical-Surgical Inc. Corporate Office

Classification: Class II

Status: Ongoing

Report Date: 20250730

Initiation Date: 20250421

Termination Date:

CGMP Deviations; potential temperature excursions due to transit delays

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.