Wed Dec 18 2024
cGMP Deviations: Temperature excursion
Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
---|---|---|---|
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 | Antares Pharma, Inc. | Virgina | 5 cartons/20 units each carton |