14,450 recalls · Class II, newest first
Reason 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.
Reason Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Reason Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Reason 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.
Reason 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.
Reason 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.
Reason 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.
Reason 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.
Reason GMP Deviations: A silicone particulate was noted in Ozurdex.
Reason CGMP Deviations
Reason Failed dissolution specifications
Reason CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.