Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle recall — FDA D-0676-2026
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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10,685 detailed records are currently available in this category.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of Assurance of Sterility
Lack of assurance of Sterility:
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Incorrect product formulation: bag did not contain copper and famotidine per label.
Subpotent Drug
Non-Sterility: Due to presence of Aspergillus penicillioides.
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Defective container:may contain bottles with incomplete seals
CGMP Deviations; deficiencies observed during FDA inspection
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