Product: Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.
Reason for recall: Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Recall initiated: 20191015
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated