8046255 Canada Inc. DBA Viatrexx Viatrexx-Infla, 10 mL Sterile multi-dose vial recall — FDA D-0334-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Subpotent Drug
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
CGMP Deviations: Presence of NDMA impurity detected in product.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
CGMP Deviations: Presence of NDMA impurity detected in product.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
CGMP Deviations: Presence of NDMA impurity detected in product.
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
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