CINACALCET
Generic: CINACALCET
CINACALCET is FDA application ANDA209403, sponsored by HETERO LABS LTD V. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).