D-0539-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 30, 2025
- Initiation Date
- April 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 Pre-filled syringes
Product Description
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Reason for Recall
CGMP Deviations; potential temperature excursions due to transit delays
Distribution Pattern
Within the U.S - OH, VA, FL.
Code Information
Lot: 1178382, Expiration date: 3/31/2027