FDA recall D-0116-2025

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

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

Distribution

Virgina

Key facts

Status: Terminated
Initiation date: 2024-09-11
Report date: 2024-12-18
Termination date: 2025-08-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2025