FDA recall D-0348-2020

8046255 Canada Inc. DBA Viatrexx · Class II · drug

Product

Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.

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.

Key facts

Status
Terminated
Initiation date
2019-10-15
Report date
2019-11-20
Termination date
2020-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Beloeil, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0348-2020