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Failed dissolution specifications - low dissolution results at S3 stage.
Labeling: Incorrect or Missing Lot and/or Exp Date
During an FDA foreign inspection, it was discovered that Wheat was not properly declared on the product labeling. Wheat is an ingredient in the noodles contained in the product. Wheat is listed in the Contains statement.
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
The allergens such as soy, milk, almond, coconut, hazelnut, and/or wheat are declared on an insert label inside of the assorted boxes, and not declared on the exterior of the boxes.