Viatrexx-Prolo Recalled Due to Lack of Assurance of Sterility
Viatrexx Bio Incorporated is recalling 42 vials of Viatrexx-Prolo 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: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Viatrexx Bio Incorporated is recalling 42 vials of Viatrexx-Prolo, a 10 mL sterile multi-dose vial prescription medication. 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 identified by Item VSPC0558 and NDC 73069-443-41. The specific lot number is 19-S00016, 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 affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 42
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-S00016
- 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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