FDA-Drug2024-12-18Class II
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
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
cGMP Deviations: Temperature excursion
Sold states
Virgina
Affected count
5 cartons/20 units each carton
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2025Don't want to check this manually?
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