Viatrexx-GI
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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.
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.
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.
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 Sterility Assurance.
Lack of Sterility Assurance.
Lack of Sterility Assurance.
Lack of Sterility Assurance.
Lack of Assurance of Sterility; bags have potential to leak
Lack of Assurance of Sterility; bags have potential to leak
GMP Deviations: potential glass contamination
GMP Deviations: potential glass contamination
GMP Deviations: potential glass contamination
Crystallization: Presence of particulate matter identified as API crystallization
Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.