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The firm was notified by one of their customers that during a random testing by ODA the product test positive for Listeria monocytogenes.
Potential contamination with Listeria Monocytogenes
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Undeclared Egg
Undeclared Egg, Yellow #5, Red #40, and Blue #1.
Undeclared Allergen
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Undeclared milk and egg
Undeclared milk
contains undeclared milk
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Product Mix-up: Incorrect diluent component included in the kit.
Potential to be contaminated with Listeria monocytogenes.
Product contains high levels of undeclared sulfites.
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
May contain undeclared milk
Non-Sterility: firm's third party lab confirmed microbial contamination.
Ingredient used possibly contaminated with Salmonella
Ingredient used in manufacturing tested positive for Salmonella