PlainRecalls
FDA Drug Moderate Class II Terminated

Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.

Reported: November 20, 2019 Initiated: October 15, 2019 #D-0329-2020

Product Description

Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.

Reason for Recall

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

Details

Units Affected
12 vials
Distribution
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Location
Beloeil, N/A

Frequently Asked Questions

What product was recalled?
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.. Recalled by 8046255 Canada Inc. DBA Viatrexx. Units affected: 12 vials.
Why was this product recalled?
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0329-2020.