PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Reported: July 30, 2025 Initiated: April 21, 2025 #D-0538-2025
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
Reason for Recall
CGMP Deviations; potential temperature excursions due to transit delays
Details
- Recalling Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Units Affected
- 6 Pre-filled syringes
- Distribution
- Within the U.S - OH, VA, FL.
- Location
- Richmond, VA
Frequently Asked Questions
What product 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. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 6 Pre-filled syringes.
Why was this product recalled? ▼
CGMP Deviations; potential temperature excursions due to transit delays
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2025. Severity: Moderate. Recall number: D-0538-2025.
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