FDA-Drug2025-07-30Class II
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
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
6 Pre-filled syringes
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0538-2025Don't want to check this manually?
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