The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
Category Archives: Food Safety News
FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes
The U.S. Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin. The product is derived from horse plasma and contains a mixture of antibody fragments that neutralize all of the seven botulinum nerve toxin serotypes known to cause botulism.
FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, Ga. The recall of all sterile products is due to the FDA’s preliminary findings of practices at the site which raise concerns about a lack of sterility assurance. This expanded recall is due to reports of five patients who have been diagnosed with serious eye infections associated with use of Avastin (bevacizumab) repackaged into syringes by CSCP.
FDA approves Dotarem, a new magnetic resonance imaging agent
The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
La Preferida, Inc. Issues A Voluntary Recall Of La Preferida Whole Pinto Beans 29 OZ. (Water & Salt)
La Preferida, Inc. is voluntarily recalling 4,734 cases (56,808 cans) of La Preferida Whole Pinto Beans 29 oz. (Water & Salt). Can Code: PINTO LP, BEST BY 01/03/2015, “Time” 3003. The manufacturer’s preliminary inspection indicates 420 cans may not have been fully processed, which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed.
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Natura Pet Issues Voluntary Recall of Specialized Dry Pet Foods Due to Possible Health Risk
Natura Pet Products is voluntarily recalling specific lots of dry pet food because it has the potential to be contaminated with Salmonella. No Salmonella-related illnesses have been reported.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
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FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J, a specialty pharmacy licensed by the State of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.
FDA warns consumers not to eat certain ProtiDiet High Protein Chocolate Dream Bars manufactured by Pro-Amino International, Inc., Quebec, Canada
Pro-Amino International Inc., of Saint-Eustache, Quebec, Canada, is recalling the ProtiDiet High Protein Chocolate Dream Bars. The recalled product may contain Salmonella.
Federal judge approves consent decree with New Jersey bakery
The U.S. Food and Drug Administration announced that a federal judge has approved a consent decree of permanent injunction against Butterfly Bakery Inc., a bakery based in Clifton, New Jersey, and its president, Brenda Isaac, for unlawfully distributing misbranded food products, such as muffins and snack cakes.
FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers
The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.