Drug recall D-0539-2025
Product
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
Lots and codes
Lot: 1178382, Expiration date: 3/31/2027
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Quantity
- 2 Pre-filled syringes
- Distribution
- Within the U.S - OH, VA, FL.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 21, 2025
Related products
- Evenity – drug information
- NDC 55513-509 Evenity · Romosozumab 105 mg/1.17mL · Amgen, Inc
- NDC 55513-880 Evenity · Romosozumab 105 mg/1.17mL · Amgen, Inc
- NDC 55513-998 Evenity · Romosozumab 105 mg/1.17mL · Amgen, Inc