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Lack of Processing Controls.
Product contains insufficient Higenamine and the label incorrectly declares Cayenne Pepper (CapsiMax) and Choline Bitartrate.
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Lack of Sterility Assurance.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.