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Temperature Abuse
Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Product contains undeclared FD&C Red No. 40.
Subpotent
Undeclared Red #40
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Undeclared ingredients on retail packaging, including but not limited to certified colors Red #40 and Blue #1
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Pasteurized donor human milk may contain trace amounts of dextromethorphan.
Incorrect labeling on bottom of packaging (undeclared peanuts).
Failed Impurity/Degradation Specifications
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Failed Dissolution Specifications