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cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Subpotent drug
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Labeling: Missing Label
Failed Tablet/Capsule Specifications
Crystallization