Hylenex Recombinant Injection, Solution
FDA Recall NDC 18657-117
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hylenex Recombinant (NDC 18657-117). A significant event, classified as Class II, was initiated on Sep 11, 2024 by Antares Pharma, Inc.. The reported reason for this action was: "cGMP Deviations: Temperature excursion"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP Deviations: Temperature excursion
Sep 11, 2024
Dec 18, 2024
5 cartons/20 units each carton
Recall Profile & Regulatory Data
Event ID
95830
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Virgina
Termination Date
Aug 20, 2025
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
Batch or Lot Expiration Information
Lot# Serial # 100000831961 100000820688 100000820689 100000820515
Affected Packages Involved in this Recall
18657-117-01Product
18657-117-02Product
18657-117-04Product
1000008319Product
1000008206Product
1000008205Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
