Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Viatrexx-Prolo Recalled by 8046255 Canada Inc. DBA Viatrexx Due to Lack of Assurance of Sterility: products manufactured in...

Date: October 15, 2019
Company: 8046255 Canada Inc. DBA Viatrexx
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact 8046255 Canada Inc. DBA Viatrexx directly.

Affected Products

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

Quantity: 42 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About 8046255 Canada Inc. DBA Viatrexx

8046255 Canada Inc. DBA Viatrexx has 23 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report