D-0539-2025 Class II Ongoing
FDA drug recall D-0539-2025 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Apr 21, 2025 and is designated Class II. Reason for recall: CGMP Deviations; potential temperature excursions due to transit delays The recall status is ongoing. Affected quantity: 2 Pre-filled syringes.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 30, 2025
- Initiation Date
- Apr 21, 2025
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0539-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026