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Reason Chemical contamination: product contains elevated levels of undeclared lead.
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Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical contamination: product contains elevated levels of undeclared lead.
Reason Chemical Contamination: product contains elevated levels of undeclared lead.
Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Reason Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Reason Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Reason CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.