Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer
The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
Voluntary Recall Notice of McCormick Ground Oregano Due to Possible Salmonella Risk
McCormick & Company, Incorporated is initiating a voluntary recall of McCormick® Ground Oregano, 0.75 oz bottle, UPC 0-523561-6 with code dates BEST BY AUG 21 16 H and AUG 22 16 H due to possible contamination with Salmonella. This recall does not impact any other McCormick Ground, Whole or Oregano Leaves products.
FDA warns consumers about fraudulent Ebola treatment products
The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.
Amgen Issues Voluntary Recall of Aranesp® (darbepoetin alfa) (500 mcg) Prefilled Syringes in Several Countries Outside of the United States Due to the Presence of Visible Particulates
Amgen (NASDAQ:AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp® (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A are being recalled as a precautionary measure.
Baxter Voluntarily Initiates U.S. Recall of Two Lots of Peritoneal Dialysis Solution Due to Presence of Particulate Matter
Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process.
FDA approves new type of sleep drug, Belsomra
The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
Baxter Initiates Voluntary Recall of One Lot of 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solution
Baxter International Inc. announced today it is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, a portion of which was released to customers. The recall is being initiated as a result of particulate matter found near the administration port.
Sunfood Recalls Organic Carob Powder Because Of Possible Health Risk
Sunfood of El Cajon, CA is recalling Organic Carob Powder, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
FDA approves donor lung preservation device that may result in more lung transplants
Today, the U.S. Food and Drug Administration approved the XVIVO Perfusion System (XPS) with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether the lung is viable for transplantation.