FDA (Drugs) recall action 84055
The FDA (Drugs) publishes a recall like this one as 23 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 23 pages.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Viatrexx Bio Incorporated is recalling 42 vials of Viatrexx-Prolo because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Mesenchyme vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.
Viatrexx Bio Incorporated is recalling Viatrexx-MuSkel-Neural vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Systemic Detox vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.
Viatrexx Bio Incorporated is recalling Viatrexx-Neuro vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.
Viatrexx Bio Incorporated is recalling Viatrexx-GI sterile multi-dose vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.
Viatrexx Bio Incorporated is recalling Viatrexx-Collagen vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling 13 vials of Viatrexx-Facial because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Infla vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.
Viatrexx Bio Incorporated is recalling Viatrexx-Intra-Cell vials because they were manufactured in a manner that cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Neuro 3 vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Hair sterile multi-dose vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Articula vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide and in Puerto Rico.
Viatrexx-Arthros is being recalled because it was manufactured in a manner that cannot guarantee sterility. The product is distributed to physicians nationwide.
Viatrexx Bio Incorporated is recalling Viatrexx-Connectissue vials because they were manufactured in a manner that cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Adipose vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.
Viatrexx Bio Incorporated is recalling Viatrexx-Lymph 1 vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling 18 vials of Viatrexx-Immunexx because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling 19 vials of Viatrexx-Ouch because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Male+ sterile vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-ANS/CNS vials because they were manufactured in a manner that cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Ithurts sterile multi-dose vials because the manufacturing process cannot guarantee sterility.
Viatrexx Bio Incorporated is recalling Viatrexx-Relief + sterile vials because the manufacturing process cannot guarantee sterility.