Viatrexx-Articula Recalled Due to Lack of Assurance of 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.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the significant health risk associated with a lack of sterility assurance in a sterile medical product.
Plain-English summary
Viatrexx Bio Incorporated is recalling Viatrexx-Articula, 10 mL Sterile multi-dose vials (NDC 73069-037-41). The recall involves 69 vials from Lot Number 19-S00008, which has an expiration date of May 2020.
The FDA has classified this as a Class II recall because the products were manufactured in a manner that cannot guarantee their sterility. This lack of assurance of sterility poses a potential risk to patients.
The affected product was distributed to physicians throughout the United States and Puerto Rico. Patients who have received this medication should consult their healthcare provider for guidance on next steps.
The recalled product
- Product
- Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Hazard
- Affected units
- 69
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-S00008
- 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.
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