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Mislabeling
Product may contain undeclared milk.
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Lack of Assurance of Sterility
Complaint received of foreign matter (metal) embedded in tablet.
Failed Impurities/Degradation Specifications
Superpotent and Failed Tablet/Capsule Specifications
Out-of-specification impurity test result observed at 18-month long term stability time point.
Defective Delivery System
Product is marketed as an infant formula but the required pre-market infant formula notification for this product has not been submitted to the FDA. Product tested by FDA was well above the maximum acceptable range for Iron, Potassium and Sodium, which could potentially lead to iron overload and/or electrolyte imbalances. In addition, the product did not have vitamin D, and a vitamin D deficiency can potentially lead to rickets, a softening and weakening of bones.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Failed impurities/degradation specifications
Failed Dissolution Specifications
Product recalled due to undeclared niacin.
Subpotent