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Sambrosa Care Inc. distributed an unapproved over-the-counter drug product called "Sambrosa sweet dreams Night Syrup," a combination antihistamine and nighttime sleep-aid, in violation of federal law requiring new drug approval before marketing. The product violated section 505(a) of the FD&C Act by being introduced into interstate commerce without approval and was misbranded under section 502(ee), with marketing claims on the company's website and product labeling establishing its intended use as a drug for treating allergy symptoms and promoting sleep. The company marketed and sold the product through its website at sambrosa.com without obtaining the required FDA approval for this combination drug formulation.