Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Product type
Drug
Status
Terminated
Report date
2024-12-18
Distribution
Virgina
Firm state
VA
Product quantity
5 cartons/20 units each carton
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
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
Code / lot info
Serial # 100000831961 100000820688 100000820689 100000820515
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.