Drug 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
D-0116-2025
Product summary
- Event
- Event 95830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cartons/20 units each carton
- Official record key
drug-enforcement:D-0116-2025
Official wording
Reason: cGMP Deviations: Temperature excursion
Code information: Serial # 100000831961 100000820688 100000820689 100000820515
Distribution pattern: Virgina
Derived failure modes
-
Manufacturing or process control
cGMP Deviations