18,003 recalls, newest first
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
GMP Deviations: A silicone particulate was noted in Ozurdex.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations
Failed dissolution specifications
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.