Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.
CloverSnare™ 4-Loop Vascular Retrieval Snare Recall
On July 10, 2014, Cook Medical initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments and the potential need for intervention to retrieve the separated snare.
FDA approves new drug to treat a form of Gaucher disease
The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.
nSPIRED Natural Foods, Inc. Voluntarily Recalls Certain Retail Lots Of Arrowhead Mills® Peanut Butters, Maranatha® Almond Butters And Peanut Butters And Specific Private Label Nut Butters Because Of Possible Health Risk
nSpired Natural Foods, Inc. is voluntarily recalling certain retail lots of Arrowhead Mills® Peanut Butters, MaraNatha® Almond Butters and Peanut Butters and specific private label nut butters (listed below) packaged in glass and plastic jars because they have the potential to be contaminated with Salmonella.
Turkish man pleads guilty to importing illegal cancer drugs
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.