Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.
Reported: November 20, 2019 Initiated: October 15, 2019 #D-0339-2020
Product Description
Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.
Reason for Recall
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Details
- Recalling Firm
- 8046255 Canada Inc. DBA Viatrexx
- Units Affected
- 3 vials
- Distribution
- Distributed to physicians Nationwide throughout the United States and Puerto Rico.
- Location
- Beloeil, N/A
Frequently Asked Questions
What product was recalled? ▼
Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.. Recalled by 8046255 Canada Inc. DBA Viatrexx. Units affected: 3 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0339-2020.
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