Recall D-0538-2025

US Class II Ongoing · initiated 2025-04-21

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office, VA

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

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