FDA recall D-0538-2025

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

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

Distribution

Within the U.S - OH, VA, FL.

Key facts

Status
Ongoing
Initiation date
2025-04-21
Report date
2025-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0538-2025