Viatrexx-Mesenchyme Recalled Due to Lack of Assurance of Sterility
Viatrexx Bio Incorporated is recalling Viatrexx-Mesenchyme 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, and the hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of infection or serious injury.
Plain-English summary
Viatrexx Bio Incorporated is recalling Viatrexx-Mesenchyme, 10 mL sterile multi-dose vials, due to a lack of assurance of sterility. The recall involves 7 vials from Lot Number 19-S00018, which expired in May 2020. The product is prescription-only and was distributed to physicians throughout the United States and Puerto Rico.
The recall was initiated because the products were manufactured in a manner that cannot guarantee their sterility. This classification is designated as Class II by the FDA. No specific illnesses or injuries are reported in the source text.
Physicians and healthcare facilities should stop using the affected vials and contact the recalling firm for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Affected units
- 7
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-S00018
- 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
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