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Allergen not listed in the Contains statement: Sesame
Subpotent Drug
Sub-Potent Drug: Subpotent assay results during stability testing.
Mislabeling
Failed Impurity/Degradation Specifications
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
Downstream recall of a dietary supplement ingredient that was manufactured out of specification.
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Failed Impurities/Degradation Specifications.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Presence of a foreign substance: black hair found embedded in tablet.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.