Drug recall D-0116-2025

Class II Terminated reported Dec 18, 2024

Product

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

Lots and codes

Serial # 100000831961 100000820688 100000820689 100000820515

Recall details

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Quantity
5 cartons/20 units each carton
Distribution
Virgina
Type
Voluntary: Firm initiated
Recall initiated
September 11, 2024
Terminated
August 20, 2025

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