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.
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.
Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination -2
Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5 Percent IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold.
Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance
Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products. The expanded recall follows the firm’s initial recall of Avastin due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product.Â
New Chapter, Inc. Issues Voluntary Recall Undeclared soy identified in one lot of Probiotic Elderberry dietary supplement
New Chapter, Inc. is voluntarily recalling a limited number of packages of its 90 count Probiotic Elderberry dietary supplement because it may contain an undeclared allergen – soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.Â
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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