FDAHealthApril 21, 2025
Mckesson Medical-Surgical Inc. Corporate Office — PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
⚠️ CGMP Deviations; potential temperature excursions due to transit delays
Is this relevant to me?
- Geography
- OH, VA, FL
- Source agency
- FDA
- Category
- Health
- Published
- April 21, 2025
Within the U.S - OH, VA, FL.
What's affected?
- Product
- PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
- Brand
- PROLIA
- Lot code
- 1180924
Additional details
Lot: 1180924, Expiration date: 6/30/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6 Pre-filled syringes.
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