FDAClass IINovember 20, 2019

Viatrexx-Ithurts recall: Sterility Concern

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

Why was Viatrexx-Ithurts recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 19-S00004, Exp. May: 2020

Product
Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
Recalling firm
8046255 Canada Inc. DBA Viatrexx
Quantity
12 vials
Distribution
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Recall date
November 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls