Beloeil, N/A, Canada
8046255 Canada Inc. DBA Viatrexx recalls
1 recall recorded since 2018, most recently on 15 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 15 October 2019
- Terminated
- 10 December 2020
- Reason
- Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
- Distribution
- Distributed to physicians Nationwide throughout the United States and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0345-2020, D-0343-2020, D-0332-2020, D-0328-2020, D-0326-2020, D-0335-2020, D-0337-2020, D-0348-2020, D-0333-2020, D-0336-2020, D-0339-2020, D-0334-2020 and 11 more
- Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.
- Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
- Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.
- Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.
- Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.
- Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.
- Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41.
- Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.
- and 15 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.