Class II · Moderate risk Terminated
Prasugrel Tablets 5 mg
Reason Failed Dissolution Specification: Low out of specification dissolution results.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk Terminated
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution 0.5%
Reason Labeling: Incorrect or missing package insert.
Class III · Low risk Terminated
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Reason Labeling: Incorrect or missing package insert.
Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution 0.03%
Reason Labeling: Incorrect or missing package insert.
Class III · Low risk Terminated
Isotretinoin Capsules
Reason Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class II · Moderate risk Terminated
Viatrexx-ANS/CNS
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Male+
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Neuro
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Hair
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Facial
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Intra-Cell
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Relief +
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Immunexx
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Arthros
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-GI
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Mesenchyme
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Lymph 1
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Prolo
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Collagen
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Infla
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Neuro 3
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Articula
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class II · Moderate risk Terminated
Viatrexx-Systemic Detox
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.