FDA recall D-0539-2025

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

Product

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

Distribution

Within the U.S - OH, VA, FL.

Key facts

Status: Ongoing
Initiation date: 2025-04-21
Report date: 2025-07-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0539-2025