Viatrexx-Prolo recalled over sterility concerns

Recall date

October 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

8046255 Canada Inc. DBA Viatrexx recalls Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC05…

Recall number

D-0336-2020

FDA classification

Class II

Brand / firm

8046255 Canada Inc. DBA Viatrexx

Sold / distributed

Distributed to physicians Nationwide throughout the United States and Puerto Rico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.