Viatrexx-Ithurts Recalled Due to Lack of Assurance of Sterility
Viatrexx Bio Incorporated is recalling Viatrexx-Ithurts sterile multi-dose vials because the manufacturing process 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the snippet, the agency classification and the nature of the defect (sterility failure in a sterile product) align with the Severe criteria for Class II recalls where risk is significant.
Plain-English summary
Viatrexx Bio Incorporated is recalling Viatrexx-Ithurts, 10 mL sterile multi-dose vials (NDC 73069-270-41). 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-S00004 with an expiration date of May 2020. The recall involves 12 vials per unit. These products were distributed to physicians nationwide throughout the United States and Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer or their supplier for further instructions on return or disposal.
The recalled product
- Product
- Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 12
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-S00004
- 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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