Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Product type
Drug
Status
Ongoing
Report date
2025-07-30
Distribution
Within the U.S - OH, VA, FL.
Firm state
VA
Product quantity
6 Pre-filled syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations; potential temperature excursions due to transit delays
Product description
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Code / lot info
Lot: 1180924, Expiration date: 6/30/2027.
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.