8046255 Canada Inc. DBA Viatrexx recalls Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC040
Recalled November 20, 2019 · FDA recall D-0347-2020 · 8046255 Canada Inc.
Hazard
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. · FDA Class II
Units
2 vials
Sold at
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Description
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Product
Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41.
Manufacturer(s)
8046255 Canada Inc. DBA Viatrexx
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →