PROLIA recalled over manufacturing violations
- Recall date
- April 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mckesson Medical-Surgical Inc. Corporate Office recalls PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks,…
- Recall number
- D-0538-2025
- FDA classification
- Class II
- Brand / firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Sold / distributed
- Within the U.S - OH, VA, FL.
Why it was recalled
CGMP Deviations; potential temperature excursions due to transit delays
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
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