FDAFDA · Food and drugs·Recall number D-0539-2025
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.
Published July 30, 2025 · Recall initiated: April 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; potential temperature excursions due to transit delays
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EVENITY
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- Within the U.S - OH, VA, FL.
- Lot
- Lot: 1178382, Expiration date: 3/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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