WhichRecall
Class IIReported 2025-07-30

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.

Recalled by Mckesson Medical-Surgical Inc. Corporate Office

Reason for Recall

CGMP Deviations; potential temperature excursions due to transit delays

Advertisement
Recall Number
D-0539-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-04-21
Reported
2025-07-30
Distribution
Within the U.S - OH, VA, FL.
Code Info
Lot: 1178382, Expiration date: 3/31/2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement