Viatrexx-Neuro Recalled Due to Lack of Assurance of Sterility
Viatrexx Bio Incorporated is recalling Viatrexx-Neuro vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of serious health consequences.
Plain-English summary
Viatrexx Bio Incorporated is recalling 13 vials of Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only. The recall is due to a lack of assurance of sterility, as the products were manufactured in a manner that cannot guarantee their sterility.
The affected product is identified by Item VSPC0460, NDC 73069-375-41, Lot Number 19-S00020, with an expiration date of May 2020. The product was distributed to physicians throughout the United States and Puerto Rico.
Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their local FDA office for further instructions.
The recalled product
- Product
- Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Sterile Injection
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Numbers: 19-S00020
- Exp. May: 2020
Distribution
Part of a larger recall action
This product is one of 23 recalled by 8046255 Canada Inc. DBA Viatrexx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 23 products in this recall →Related recalls
Same manufacturer · 8046255 Canada Inc. DBA Viatrexx
See all →- SevereViatrexx-Mesenchyme Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2019-11-20
- SevereViatrexx-MuSkel-Neural Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2019-11-20
- SevereViatrexx-Systemic Detox Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2019-11-20
- SevereViatrexx-GI Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2019-11-20
- SevereViatrexx-Collagen Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-11-20
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22