Viatrexx-Collagen Recalled for Lack of Sterility Assurance
Viatrexx Bio Incorporated is recalling Viatrexx-Collagen vials 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures are categorized as Severe.
Plain-English summary
Viatrexx Bio Incorporated is recalling Viatrexx-Collagen, 10 mL sterile multi-dose vials (NDC 73069-095-41). The recall involves 22 vials from Lot 19-S00014, which expire in May 2020.
The recall was initiated because the products were manufactured in a manner that cannot guarantee sterility. This lack of assurance of sterility poses a potential risk to patients.
The affected products were distributed to physicians nationwide in the United States and Puerto Rico. Patients and healthcare providers should stop using the recalled vials and contact their healthcare provider for guidance.
The recalled product
- Product
- Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
- Manufacturer
- 8046255 Canada Inc. DBA Viatrexx
- Category
- Drug — Biologic
- Hazard
- Affected units
- 22
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-S00014
- 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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