Viatrexx-Immunexx Recalled Due to Lack of Sterility Assurance
Viatrexx Bio Incorporated is recalling 18 vials of Viatrexx-Immunexx because the manufacturing process cannot guarantee sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall involving a sterile medical product with a lack of sterility assurance, which poses a significant risk of infection.
Plain-English summary
Viatrexx Bio Incorporated is recalling 18 vials of Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Item VSPC0270, NDC 73069-244-41. The recall is due to a lack of assurance of sterility, as the products were manufactured in a manner that cannot guarantee sterility.
The affected lot number is 19-S00023, 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 recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Biologic
- Hazard
- Affected units
- 18
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-S00023
- 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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighCompounded Semaglutide Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-09-11
- HighAlkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-07-31
- HighAssurance Infusion Recalls TRIMIX Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- HighTirzepatide Injectable Drug Recalled for Sterility Assurance Defect
FDA (Drugs) · 2024-09-11
- SeverePromise Pharmacy Recalls Dexpanthenol Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- HighTirzepatide Injectable Vials Recalled for Sterility Assurance
FDA (Drugs) · 2024-09-11