Mckesson Medical-Surgical Inc. Corporate Office recalls PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,
Recalled July 30, 2025 · FDA recall D-0538-2025 · Mckesson Medical-Surgical Inc. Corporate Office
Hazard
CGMP Deviations; potential temperature excursions due to transit delays · FDA Class II
Units
6 Pre-filled syringes
Sold at
Within the U.S - OH, VA, FL.
Description
CGMP Deviations; potential temperature excursions due to transit delays
Product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Manufacturer(s)
Mckesson Medical-Surgical Inc. Corporate Office
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →