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Lack of Assurance of Sterility
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Undeclared Allergen: Milk.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Product was analyzed and found to contain 1,3- dimethylbutylamine which was not declared on the label and is a prohibited substance.
Superpotent
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Failed Impurities/Degradation Specifications: OOS results for known compound.