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Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai