On January 10, 2020, the FDA issued a warning letter to Marco Pharma International LLC, which found the company's Absinthium Herbal Liquid Extract 100 ml (Absinthium), promoted for "digestive support", and other products, including S21 Multi Somaplex 100 ml (Multi Somaplex), S9 Molybdenum Somaplex 30 ml (Molybdenum), and S17 Manganese-Copper-Cobalt Somaplex 30 ml (Manganese-Copper-Cobalt) to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.
These violations include failure to establish the required specifications for quality control of the dietary supplement and failure to establish and follow written procedures for the responsibilities of the quality control operations, as required by federal regulations.
In addition, the products Para A Herbal Liquid Extract 59 mL (Para A), Absinthium Herbal Liquid Extract 100 mL (Absinthium), and S21 Multi Somaplex 100 ml (Multi Somaplex) are misbranded because the presentation of the nutrition information does not comply with federal regulations.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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