Drug product
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
D-0538-2025
Product summary
- Event
- Event 97110
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 Pre-filled syringes
- Official record key
drug-enforcement:D-0538-2025
Official wording
Reason: CGMP Deviations; potential temperature excursions due to transit delays
Code information: Lot: 1180924, Expiration date: 6/30/2027.
Distribution pattern: Within the U.S - OH, VA, FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations