Hylenex recombinant injection recalled over manufacturing violations

Recall date

September 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mckesson Medical-Surgical Inc. Corporate Office recalls Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for an…

Recall number

D-0116-2025

FDA classification

Class II

Brand / firm

Mckesson Medical-Surgical Inc. Corporate Office

Sold / distributed

Virgina

Why it was recalled

cGMP Deviations: Temperature excursion

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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