The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
Food Product Recall by the Gift Shop at Buffalo Trace Distillery Due to Undeclared Allergens
The Gift Shop at Buffalo Trace Distillery today voluntarily recalled all non-expired products listed below due to mislabeling and undeclared allergens. People who have an allergy or severe sensitivity to wheat, soy, anchovy, and/or milk, run the risk of serious or life-threatening allergic reaction if they consume these products.
Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed
Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level.
The recall resulted from a recent inspection conducted by the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy where visible particulates (filaments) were observed in vials of sterile compounded products: TRIMIX, BIMIX (Lot 02252013@3), ALPROSTADIL, DMSO 50 PERCENT – IRRIGATION (Lot
03122013@19), and BACTERIOSTATIC WATER FOR INJECTION (Lot 01072013@28).
La Preferida, Inc. Issues A Voluntary Recall Of La Spanish Version – 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.
Gold Standard Baking Issues Allergy Alert on Undeclared Walnuts in Sweet P’s Bake Shop Branded Caramel Apple Danish Coffee Cake
Gold Standard Baking of Chicago, IL is recalling 1,134 cases of Sweet P’s Bake Shop branded Caramel Apple Danish Coffee Cake because it contains undeclared walnuts. People who have an allergy or severe sensitivity to walnuts and other tree nuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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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 approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients
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.
FDA issues proposal to improve the quality of automated external defibrillators
The U.S. Food and Drug Administration (FDA) today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.
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.
Jones Natural Chews Co Recalls Woofers Dog Treats Because Of Possible Salmonella Health Risk
Jones Natural Chews Co of Rockford, IL is recalling 245 boxes of Woofers (beef patties) because it has the potential to be contaminated with Salmonella. Salmonella can affect animals and there is risk to humans from handling contaminated pet products.