FDAFDA · Food and drugs·Recall number D-0116-2025
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
Published December 18, 2024 · Recall initiated: September 11, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: Temperature excursion
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYLENEX RECOMBINANT
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- Virgina
- Lot
- Serial # 100000831961 100000820688 100000820689 100000820515
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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