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  4. Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance
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COMPANY ANNOUNCEMENT

Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Lack of sterility assurance
Company Name:
Viatrexx Bio Incorporated
Brand Name:
Brand Name(s)
Viatrexx
Product Description:
Product Description
Sterile injectable products

Company Announcement

Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cannot guarantee its sterility.

Administration of a non-sterile product, intended to be sterile, may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome. To date, Viatrexx has not received any reports of adverse events related to this recall.

The products are used as sterile injectables and packaged in a 10 mL vial. The affected lots are included in the table.

Lot # Exp Product NDC #
19-S00001 May: 2020 Connectissue 73069-100-41
19-S00002 May: 2020 Muskel-Neural 73069-347-41
19-S00003 May: 2020 Ouch 73069-402-41
19-S00004 May: 2020 it hurts 73069-270-41
19-S00005 May: 2020 Adipose 73069-024-41
19-S00007 May: 2020 Systemic Detox 73069-500-41
19-S00008 May: 2020 Articula 73069-037-41
19-S00010 May: 2020 Neuro 3 73069-373-41
19-S00012 May: 2020 Infla 73069-249-41
19-S00014 May: 2020 Collagen 73069-095-41
19-S00016 May: 2020 Prolo 73069-443-41
19-S00017 May: 2020 Lymph 1 73069-310-41
19-S00018 May: 2020 Mesenchyme 73069-102-41
19-S00019 May: 2020 GI 73069-189-41
19-S00021 May: 2020 Arthros 73069-035-41
19-S00023 May: 2020 Immunexx 73069-244-41
19-S00024 May: 2020 Relief + 73069-450-41
19-S00025 May: 2020 Intra-Cell 73069-250-41
19-S00026 May: 2020 Facial 73069-164-41
19-S00020 May 2020 Neuro 73069-375-41
19-S00022 May 2020 Male + 73069-320-41
19-S00009 May 2020 Hair 73069-206-41
19-S00027 May 2020 ANS/CNS 73069-039-41

These products have a very limited distribution to less than 32 US practitioners. They are only for the 10mL sterile injectable products.

Viatrexx is notifying its customers by email and phone and is arranging for the return and replacement of all recalled products. Practitioners that have any of the 10 mL sterile injectable product which is being recalled should stop using/return to Viatrexx or discard.

Consumers with questions regarding this recall can contact Viatrexx by calling 450-536-1295 or info@viatrexx.com, from Monday to Friday, between 9 am to 3 pm EST (closed between 1 and 2 pm EST). Consumers should contact their physician if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Viatrexx
450-536-1295
info@viatrexx.com
Media:
Stephen Emond or Barry Saunders
450-536-1295

Product Photos