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

Company Contact:

Stephen Emond or Barry Saunders
450-536-1295

FOR IMMEDIATE RELEASE – October 15, 2019(Revised November 5th) – 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 2pm 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: www.fda.gov/medwatch/report.htm1
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address onthe 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PDF version of recall

Adipose C of A

Articula C of A

Conectissue C of A

Hair C of A

Infla C of A

Intra-Cell C of A

Ithurts C of A

Lymph 1 C of A

Mesenchyme C of A

MuSkel-Neural C of A

Neuro 3 C of A

Neuro C of A

Ouch C of A

Prolo C of A

Systemic Detox C of A

Professional section | Viatrexx Bio Incorporated