Drug Enforcement D-0116-2025

cGMP Deviations: Temperature excursion

Status

Terminated

Classification

Class II

Report Date

December 18, 2024

Termination Date

August 20, 2025

Product Information

Product description
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
Product quantity
5 cartons/20 units each carton
Reason for recall
cGMP Deviations: Temperature excursion
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Virgina

Location & Firm

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0116-2025
Event ID
95830
Recall initiation date
September 11, 2024
Center classification date
December 10, 2024
Code info
Serial # 100000831961 100000820688 100000820689 100000820515
More code info
—