Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
Nutrizone Recalls Various Lots of Multiple Dietary Supplements Because of Possible Salmonella Health Risk
NutriZone, LLC of Houston, Texas is recalling 4 different dietary supplements because it has the potential to be contaminated with Salmonella. Salmonella, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
New York raw milk cheese company ordered to stop sales for food safety violations
FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.
MarcasUSA, LLC Emite Retiro Voluntariamente a Nivel Nacional de Pasta De Lassar Andromaco Protector de la Piel con 25% de óxido de Zinc, en Tubos de 60 Gramos, Debido a Contaminación Microbiana
PARA PUBLICACIÓN INMEDIATA – 29 de marzo de 2018 – El Segundo, CA, MarcasUSA, LLC e Industria Farmacéutica Andromaco, S.A. de C.V. están retirando voluntariamente tres lotes de Pasta De Lassar Andromaco Protector de la Piel con 25% de óxido de zinc, en tubos de 60 gramos, al nivel minorista. El análisis de la FDA de este producto confirmó que Pasta De Lassar Andromaco está contaminado con altos niveles de bacterias y hongos. El lote específico asociado a los hallazgos positivos se puso en cuarentena y se destruyó, ninguna pieza fue vendida en los EE. UU. Sin embargo, debido a la cantidad y el tipo de contaminación, los tres lotes restantes en el mercado de los EE. UU. se retiran como una gran medida de precaución.
El uso del producto contaminado podría aumentar el riesgo de infección. Hasta la fecha, MarcasUSA no ha recibido ningún informe de eventos adversos relacionados con este retiro del mercado.
MarcasUSA, LLC Issues Voluntary Nationwide Recall of Pasta De Lassar Andromaco Skin Protectant 25% Zinc Oxide 60g Due to Potential Contamination
FOR IMMEDIATE RELEASE – March 29, 2018 – El Segundo, CA, MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. is voluntarily recalling four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution.
Use of the contaminated product could result in an increased risk of infection. To date, MarcasUSA has not received any reports of adverse events related to this recall.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review
FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
Health Nut Factory Recalls Organic Coconut Smiles Because Of Possible Health Risk
Healthy Nut Factory of Bayside, NY is recalling 7 oz. Pouches of Organic Coconut Smiles because it 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.
Target Corporation Issues a Voluntary Recall For a Variety of Frozen Products Sold at a Single Store on Oahu
Target Corp. (NYSE: TGT) is voluntarily recalling a number of frozen items sold at a single Target store on Oahu located at 1450 Ala Moana Blvd., Honolulu, Hawaii. The products were not held at an appropriate temperature and may be contaminated by spoilage organisms or pathogens, which could lead to serious or life-threatening illness if consumed. The recall includes items listed here (Item Listlink)) that were sold on March 23, 2018 through March 27, 2018. No illnesses have been reported to date.
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.