← FDA ENFORCEMENT
D-0116-2025Class II

Mckesson Medical-Surgical Inc. Corporate Office

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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 & CAPA
Reason 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

Data: U.S. FDA. 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. Open the enforcement explorer →