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Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Presence of Particulate Matter: Silicone
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Undeclared Egg
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Non-Sterility
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
The firm was notified that their labels do not list the allergens wheat and sesame.
Undeclared Peanuts in bakery product.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Undeclared egg, wheat and soy.
Undeclared egg and soy.
The firm was notified that a consumer had an allergic reaction to their product. The product did not list egg on the label.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.