Class II
Terminated
Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.
This recall has been terminated (originally issued November 20, 2019).
- Company
- 8046255 Canada Inc. Dba Viatrexx
- Recall Initiated
- October 15, 2019
- Posted
- November 20, 2019
- Recall Number
- D-0343-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8 vials
- Firm Location
- Beloeil, Canada
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
Lot Numbers: 19-S00025, Exp. May: 2020
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