Class II
Ongoing
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
- Recall Initiated
- April 21, 2025
- Posted
- July 30, 2025
- Recall Number
- D-0538-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6 Pre-filled syringes
- Firm Location
- Richmond, VA, United States
Reason for Recall
CGMP Deviations; potential temperature excursions due to transit delays
Distribution
Within the U.S - OH, VA, FL.
Lot / Code Info
Lot: 1180924, Expiration date: 6/30/2027.
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