FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.
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Nectar Foods Inc Dba Honey Mama’s Issues Allergy Alert on Undeclared Almonds in Oregon Peppermint Cacao Nectar Bar
Nectar Foods Inc., DBA Honey Mama’s of Portland, Oregon is recalling 79 Sleeves (948 units) of Oregon Peppermint bars, lot code 112918, because it may contain undeclared Almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes
glucose monitoring system, implantable glucose sensor, adults, diabetes
Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination
Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines.
Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk
NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour
Golden Star Wholesale of Troy, MI 48084 is recalling, AL Reef Dried Apricots Sour, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply
FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act