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Prescription drugs recalled for contamination, potency or labelling.
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1,993 recalls · newest first
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Failed Impurities/Degradation Specification
Failed Impurities/Degradation Specification
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Labeling: Label Mix-Up
Labeling: Label Mix-Up
Subpotent Drug
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: 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: 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.