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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment 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 recalling firm filed for Chapter 11 in September 2024.
CGMP Deviations
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations
Subpotent Drug
Subpotent Drug
Sub-Potent Drug: Subpotent assay results during stability testing.
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug
Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Dissolution Specifications.
Subpotent Drug
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.