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Recall Observatory FDA recall evidence

Drug product

Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.

D-0326-2020

October 15, 2019

Class II

Product summary

Firm
8046255 Canada Inc. DBA Viatrexx
Event
Event 84055
Status
Terminated
Classification
Class II
Quantity
24 vials
Official record key
drug-enforcement:D-0326-2020

Official wording

Reason: Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

Code information: Lot Numbers: 19-S00001, Exp. May: 2020

Distribution pattern: Distributed to physicians Nationwide throughout the United States and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility