Viatrexx-Intra-Cell Recalled Due to Lack of Sterility Assurance
Viatrexx Bio Incorporated is recalling Viatrexx-Intra-Cell vials because they were manufactured in a manner that cannot guarantee sterility.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
Viatrexx Bio Incorporated is recalling Viatrexx-Intra-Cell, 10 mL sterile multi-dose vials (NDC 73069-250-41). 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 Lot 19-S00025, with an expiration date of May 2020. The product was distributed to physicians nationwide throughout the United States and Puerto Rico.
Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Biologic
- Affected units
- 8
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-S00025
- 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-Neuro Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2019-11-20
- SevereViatrexx-GI Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2019-11-20
Same hazard · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19