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cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
potential for pieces of metal in product
Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).
Products contain undeclared allergens (milk, soy, peanut, and wheat) and undeclared sulfites, yellow 5, yellow 6, and red 40)
Salsa had pH of 4.7.
Elevated lead > 2ppm
The firm received complaints of a "rancid taste" from consumers.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Product may be contaminated with mold.
Labeling: Missing Label
Product contains undeclared soy lecithin.
Product contains undeclared hydrolyzed soy protein.
Undeclared allergen - egg
potential to be contaminated with Listeria monocytogenes
Crystallization
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle