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The recall was initiated following a report of an allergic reaction from one consumer

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Manufactured under cGMP (current Good Manufacturing Practice) conditions and meeting United States Pharmacopoeia (USP) monograph standards, this product carries FDA approval and is classified as prescription-only for licensed healthcare professionals

[PMC free article] [PubMed] [Google Scholar] 86.Nguyen-Khac E., Thevenot T., Piquet M.A., Benferhat S., Goria O., Chatelain D., Tramier B., Dewaele F., Ghrib S., Rudler M., et al