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Lack of sterility assurance.
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Subpotent
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
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.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.