Product: PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Reason for recall: CGMP Deviations; potential temperature excursions due to transit delays
Recall initiated: 20250421
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated