Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India…
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
31 FDA recalls mention Cinacalcet. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cinacalcet.
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason Failed Dissolution Specifications.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Reason CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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