Recalls and Warnings

Seller of Digestion Supplements Warned for Manufacturing Violations

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If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem.
(Date Posted: 2/4/2020)

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.

See ConsumerLab.com's answer to the question Which supplements can help with indigestion and/or heartburn?.

See related recalls and warnings:

FDA Warns Seller of Digestive Enzyme Supplements

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

Seller of Digestion, Thyroid and Vitamin D Supplements Warned For Drug Claims

Recall of Digestive Health Supplement Due to Salmonella Concern

For more information, use the link below.

Warning Letter: Marco Pharma International LLC



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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