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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
Failed Impurities/Degradation Specifications
Lack of Sterility Assurance
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Subpotent Drug
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been…
Crystallization; identified as Buprenorphine free base
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…