September 2024 FDA Recall Hylenex Recombinant by Mckesson Medical-surgical Inc. Corporate Office
D-0116-2025 - cGMP Deviations

This Class II drug recall was voluntarily initiated by Mckesson Medical-surgical Inc. Corporate Office on September 11, 2024 for the product Hylenex Recombinant. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Virgina and the recall is currently terminated.

Recall Number: D-0116-2025

Reason for Recall
cGMP Deviations: Temperature excursion
Initiated
09-11-2024
Reported
12-18-2024
Quantity
5 cartons/20 units each carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95830
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Virgina
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-20-2025
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# Serial # 100000831961 100000820688 100000820689 100000820515

Affected Packages Involved in this Recall

18657-117-01 Hylenex Recombinant
18657-117-02 Hylenex Recombinant
18657-117-04 Hylenex Recombinant