Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.

Recall Number: D-0334-2020

Firm: 8046255 Canada Inc. DBA Viatrexx

Classification: Class II

Status: Terminated

Report Date: 20191120

Initiation Date: 20191015

Termination Date: 20201210

Reason for Recall

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Product Description

Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.