FDA-Drug2019-11-20Class II

Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.

8046255 Canada Inc. DBA Viatrexx
Hazard

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

Sold states
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Affected count
18 vials
Manufactured in
1360 Louis-Marchand St, N/A, Beloeil, N/A, Canada
Products
Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2020

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