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Ingredient used in manufacturing tested positive for Salmonella
Undeclared allergen - Peanuts.
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not provide adequate iron for some infants, particularly infants born prematurely or with a low birth weight, had low iron levels at birth, or are at risk for becoming iron deficient due to illness. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear mandatory labeling statements in English.
Firm notified by customers that product labeled as Dark Chocolate Malt Balls had Dark Chocolate Peanut Butter malt balls inside - undeclared peanuts.
Superpotent Drug
Product contains high levels of undeclared sulfites.
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Potential to be contaminated with Listeria monocytogenes
Cheese may be contaminated with Listeria monocytogenes.
Product may be contaminated with Salmonella.