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.
Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance
Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall.
FDA allows marketing of new stent for treating pseudocysts of the pancreas
The U.S. Food and Drug Administration today allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts (fluid and tissue filled cavities) that form in the pancreas and are next to the stomach or small intestine. This is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.