On October 11, 2011, the Food and Drug Administration issued a Drug Safety Communication warning the public that the leukemia drug Sprycel, active ingredient dasatinib, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, known as pulmonary arterial hypertension, or PAH.
FDA: U.S. Marshals seize foods stored at Washington State facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., on Sept. 30, 2011.
CFE International Fish Exporters Issues Alert on Uneviscerated Salted, Smoked, Split Herring Lot Code: 1171, Plant Registration #2406
CFE International, Canadian Fish Exporters, Inc. Auburndale, MA is recalling Salted, Smoked, Split Herring, , Lot Number: 1171, Plant Code: 2406 Producer: Leslie Leger & Sons, Ltd. Cap Pele, NB, Canada. A routine sample collected at a retail store by New York State Department of Agriculture and Markets found the product to be uneviscerated. Clostridium botulinum spores are more likely to be concentrated in the viscera than any other portion of the fish.
Nestlé Prepared Foods Company Announces Allergy Alert and Voluntary Recall of LEAN CUISINE® Dinnertime Selects™ Chicken Fettuccini Recall Due to Package Mislabeling
Nestlé Prepared Foods Company, a business unit of Nestlé USA, is initiating the voluntary recall of a limited quantity of LEAN CUISINE® Dinnertime Selects™ Chicken Fettuccini/UPC code 13800-14880. The affected product is marked with a production code of 1253595911G and has a “best before” date of October 2012. A small quantity—less than 200 packages–of LEAN CUISINE Dinnertime Selects Lemon Garlic Shrimp product was inadvertently placed into packaging for LEAN CUISINE Dinnertime Selects Chicken Fettuccini and possibly shipped to grocers in Alaska, Florida, Idaho, Oregon and Washington State.
Whole Milk With An Expiration Date Of 10/22/11 From Farmers All Natural Creamery Voluntarily Recalled Due To Possible Health Concerns
The Iowa Department of Agriculture and Land Stewardship today said that whole milk with an expiration of October 22, 2011 from Farmers All Natural Creamery in Wellman, Iowa is the subject of a voluntary recall due to concerns that at least some of the milk from that facility may not have been properly pasteurized.
FDA approves combination therapy Juvisync
The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
FDA, CMS launch pilot program for voluntary parallel review of innovative devices
The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.
Fruit Fresh Up, Inc. Recalls Fresh Cut Cantaloupe and Cut Mixed Fruit Containing Cantaloupe Distributed in New York State Because of Possible Health Risk
Fruit Fresh Up, Inc. of Depew, New York is recalling approximately 4,800 individual packages of FRESH CUT CANTALOUPE AND CUT MIXED FRUIT CONTAINING CANTALOUPE because they have 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.
Prolab Proactively Recalls Some Protein Products in Order to Correct Labeling for Items That May Have Undeclared Milk and/or Wheat and Gluten Allergens
PROLAB NUTRITION INC. (PROLAB) is recalling some of its protein items that may contain undeclared milk, wheat and gluten allergens. People with an allergy or severe sensitivity to milk and/or wheat and gluten allergens may run the risk of a serious or life-threatening allergic reaction if they consume products containing these allergens.
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FDA approves Cialis to treat benign prostatic hyperplasia
The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.