CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02. Generic: CINACALCET; Brand: CINACALCET. Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit. Classification: Class II. Quantity: 63,192 bottles. Distribution: Nationwide in the USA
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Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility
Labeling: Missing Label
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.