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The FDA is warning consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances that are found in prescription drugs. These drugs could lead to serious side effects or injury. They contain chlordiazepoxide HCl (the active ingredient in Librium) and fluoxetine HCl (the active ingredient in Prozac). The supplements were also found to contain fenproporex, a stimulant that is not approved for marketing in the U.S. Consumers are advised not to use the products and to return them to the suppliers. There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin. For more information, go to http://www.fda.gov/medwatch/safety/2006/safety06.htm#Brazilian.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.