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-

FDA recall notice · announced December 18, 2024 · Mckesson Medical-surgical Inc. Corporate Office

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Virgina
Lot/code information: Serial # 100000831961 100000820688 100000820689 100000820515
Quantity: 5 cartons/20 units each carton
Status: Terminated
Products in this recall event:
- 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, Di (D-0116-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.