The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD).
FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy
The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
Allergy Alert On Undelcared Eggs In Lotte Waffles
LOTTE Confectionery Co., Ltd. (manufacturer), 21-5ka, Yangpyung-dong, Youngdeunpo-gu, Seoul, Korea, is recalling its 1.41 ounce (40g) and 5.64 ounce (160g) packages of Lotte Waffles because they contain undeclared egg ingredients.
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Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance
Oregon Compounding Centers, Inc., dba Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance
Oasis Brands, Inc Recalls Cuajada en Hoja 12oz because of Possible Health Risk
Oasis Brands, Inc of Miami, FL is recalling Cuajada en Hoja 12oz with Best By 10/01/14-
10/08/14 and 10/18/14, because it has the potential to be contaminated with 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. Although healthy
individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Hospira Issues a Voluntary Nationwide Recall of One Lot of Vancomycin Hydrochloride for Injection USP, Equivalent to 1 G Vancomycin (Sterile Powder) Due to Uncontrolled Storage During Transit
Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01NOV 2015. This action is because the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer.
HAR Maspeth Corp RECALLS Jinga brand “Pan Fried Anchovies� BECAUSE OF POSSIBLE HEALTH RISK
HAR Maspeth Corp. of Maspeth, NY, is recalling its 2 ounce and 4 ounce packages of Jinga “Pan Fried Anchovies� due to contamination with 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.
J&b European Distribution Inc. Issues Allergy Alert For Undeclared Milk In Kupiec Rice Cakes With Dark Chocolate
J&B EUROPEAN DISTRIBUTION INC. of BROOKLYN, NY is recalling 40 cases of KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 OZ. (90g), UPC # 5 906747 171742, because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet
SAM Medical Products announced today that it has begun notifying customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT).