Recalls / Class II
Class IID-0538-2025
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 name
- Prolia
- Generic name
- Denosumab
- Active ingredient
- Denosumab
- Route
- Subcutaneous
- NDC
- 55513-710
- FDA application
- BLA125320
- Affected lot / code info
- Lot: 1180924, Expiration date: 6/30/2027.
Why it was recalled
CGMP Deviations; potential temperature excursions due to transit delays
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Amgen, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 6 Pre-filled syringes
- Distribution pattern
- Within the U.S - OH, VA, FL.
Timeline
- Recall initiated
- 2025-04-21
- FDA classified
- 2025-07-21
- Posted by FDA
- 2025-07-30
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0538-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.