D-0116-2025 Class II Terminated
FDA drug recall D-0116-2025 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Sep 11, 2024 and is designated Class II. Reason for recall: cGMP Deviations: Temperature excursion The recall status is terminated (terminated Aug 20, 2025). Affected quantity: 5 cartons/20 units each carton.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 18, 2024
- Initiation Date
- Sep 11, 2024
- Termination Date
- Aug 20, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 cartons/20 units each carton
Product Description
Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
Reason for Recall
cGMP Deviations: Temperature excursion
Distribution Pattern
Virgina
Code Information
Serial # 100000831961 100000820688 100000820689 100000820515
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0116-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026