FDA-Drug2025-07-30Class II

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.

Mckesson Medical-Surgical Inc. Corporate Office
Hazard

CGMP Deviations; potential temperature excursions due to transit delays

Sold states
Within the U.S - OH, VA, FL.
Affected count
2 Pre-filled syringes
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
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.

Official notice

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

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