Recalls / Class II
Class IID-0116-2025
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
- Brand name
- Hylenex Recombinant
- Generic name
- Hyaluronidase
- Active ingredient
- Hyaluronidase (human Recombinant)
- Route
- Subcutaneous
- NDC
- 18657-117
- FDA application
- BLA021859
- Affected lot / code info
- Serial # 100000831961 100000820688 100000820689 100000820515
Why it was recalled
cGMP Deviations: Temperature excursion
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Antares Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 5 cartons/20 units each carton
- Distribution pattern
- Virgina
Timeline
- Recall initiated
- 2024-09-11
- FDA classified
- 2024-12-10
- Posted by FDA
- 2024-12-18
- Terminated
- 2025-08-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0116-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.