Baxter International Inc. announced today it has initiated a voluntary recall to the hospital/user level of one lot of 5 percent Dextrose Injection, USP and four lots of 0.9 percent Sodium Chloride Injection, USP due to particulate matter found in the solutions. Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.
Deseo Rebajar Inc. Issues Voluntary Recall of Burn 7 Capsules Due to Undeclared Active Ingredient
Deseo Rebajar Inc., is voluntarily recalling lot #MFD: 07.18.2013 (Exp: 07.17.2015) of Burn 7 Capsules to the consumer level. The FDA laboratory analysis of this dietary supplement found the Burn 7 Capsules product to contain undeclared Sibutramine.
FDA warns consumers not to use muscle growth product
The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.
FDA approves Tretten to treat rare genetic clotting disorder
The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution.
FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy
The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.
Spokane Produce, Inc. Voluntarily Recalls Victor™ Toasted Sesame Hummus Because Of Possible Health Risk
Spokane Produce, Inc., of Spokane Washington is recalling approximately 59 lbs of Victor’s Sesame Hummus due to concerns about possible Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA proposes new food defense rule
As required by the bipartisan Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply.
Concertos in Chocolate Issues Allergy Alert on Milk in Solid Milk Chocolate Santa
Concertos in Chocolate of Boulder, Colorado is recalling 450 solid milk chocolate Santas. Because of possible mislabeling it may contain undeclared milk products.
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Montana dietary supplement maker found in contempt of court
The U.S. Food and Drug Administration announced today that on Dec. 4, 2013, a Livingston, Mont., dietary supplement maker was found in civil contempt of court for repeatedly violating the terms of a consent decree of permanent injunction that resolved a 2010 civil case against the company and its owner.