Viatrexx-Adipose Recalled Due to Lack of Assurance of Sterility
Viatrexx Bio Incorporated is recalling Viatrexx-Adipose vials because the manufacturing process cannot guarantee sterility. The product was distributed to physicians nationwide.
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: The recall is classified as FDA Class II, which per the rubric corresponds to a severity score of 4 (Severe) when associated with potential adverse health consequences, such as sterility issues in medical products.
Plain-English summary
Viatrexx Bio Incorporated is recalling Viatrexx-Adipose, 10 mL sterile multi-dose vials, due to a lack of assurance of sterility. The recall involves products manufactured in a manner that cannot guarantee their sterility. The specific lot number is 19-S00005, with an expiration date of May 2020.
The affected product is a prescription-only medication distributed to physicians nationwide throughout the United States and Puerto Rico. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Physicians and healthcare providers should stop using the affected product and contact the recalling firm for instructions on how to return or dispose of the vials. Patients who have received this medication should consult their healthcare provider for guidance.
The recalled product
- Product
- Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Injectable Medication
- Affected units
- 4
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-S00005
- 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 · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighTirzepatide Injectable Drug Recalled for Sterility Assurance Defect
FDA (Drugs) · 2024-09-11
- HighAlkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-07-31
- HighTirzepatide Injectable Vials Recalled for Sterility Assurance
FDA (Drugs) · 2024-09-11
- SevereApothecary Pharma Recalls Tirzepatide Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereAdcetris IV Infusion Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2019-08-21
- SevereApothecary NAD+ Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-10-14