Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx onl...
FDA Recall #D-0116-2025 — Class II — September 11, 2024
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
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5 cartons/20 units each carton
Distribution
Virgina
Code Information
Serial # 100000831961 100000820688 100000820689 100000820515
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated