404 recalls · Class II, newest first
Reason Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Presence of precipitate
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 Presence of Foreign Tablets/Capsules
Reason Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason Lack of Sterility Assurance
Reason Failed Impurities/Degradation Specifications