Why it was recalled
cGMP Deviations: Temperature excursion
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
Lot numbers, UPCs & expiration codes
Serial # 100000831961 100000820688 100000820689 100000820515
Where it was sold
Virgina
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0116-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 11, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 5 cartons/20 units each carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
Original FDA data
Every field from FDA enforcement report D-0116-2025, exactly as published.
Show all FDA fields
- City
- Richmond
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 95830
- Address
- 9954 Maryland Drive
- Address (line 2)
- Deep Run Iii Ste. 4000
- Code information
- Serial # 100000831961 100000820688 100000820689 100000820515
- Postal code
- 23233
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0116-2025
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product quantity
- 5 cartons/20 units each carton
- Termination date
- Aug 20, 2025
- Reason for recall
- cGMP Deviations: Temperature excursion
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Virgina
- Recall initiation date
- Sep 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 10, 2024