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CGMP Deviations
Contains undeclared almonds & undeclared sesame
Product contains undeclared sulfites (7.49mg/serving)
cGMP deviations and lack of assurance of sterility.
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
CGMP Deviations; potential temperature excursions due to transit delays
Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.