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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
Subpotent and Superpotent Drug.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP violations.
CGMP violations.
Failed Impurities/Degradation Specifications.
Defective Container: Firm received complaints of broken tube at the seal.
Presence of Particulate Matter: Presence of glass particulates.
cGMP violations
cGMP violations
cGMP violations
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
cGMP violations
cGMP violations
CGMP violations