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FDARecalled Jul 30, 2025 · #D-0538-2025

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

Hazard

Class II — temporary health risk

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Description

CGMP Deviations; potential temperature excursions due to transit delays Classification: Class II Distribution: Within the U.S - OH, VA, FL.

Product details

Product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Type
Drugs
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Model numbers
1180924
UPCs