WhichRecall
Class IIReported 2025-07-30

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

Recalled by Mckesson Medical-Surgical Inc. Corporate Office

Reason for Recall

CGMP Deviations; potential temperature excursions due to transit delays

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Recall Number
D-0538-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-04-21
Reported
2025-07-30
Distribution
Within the U.S - OH, VA, FL.
Code Info
Lot: 1180924, Expiration date: 6/30/2027.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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