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Subpotent product:out of specification assay results observed during long term stability testing.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Cross Contamination with Other Products
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Undeclared FD&C Red #40
Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.
Defective Container - A defect in the side-seal which allows leakage of product.
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
Subpotent Drug