EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufa...
FDA Recall #D-0539-2025 — Class II — April 21, 2025
Product Description
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.
Reason for Recall
CGMP Deviations; potential temperature excursions due to transit delays
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2 Pre-filled syringes
Distribution
Within the U.S - OH, VA, FL.
Code Information
Lot: 1178382, Expiration date: 3/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated