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- FDA Alerts
Dec 31, 2010 - The FDA has issued updated information on atypical fractures of the femur associated with the use of bisphosphonates to treat osteoporosis. These drugs include Fosamax (alendronate sodium), Actonel (risedronate sodium), Boniva (ibandronate sodium), ...Dec 31, 2010 - Actavis is recalling certain lots of the company's fentanyl transdermal patches because they may release the active ingredient faster than they should. An accelerated release of fentanyl, a strong opioid narcotic, could lead to adverse events such a...Dec 31, 2010 - FDA is informing oncologists that recent changes in how serum creatinine is measured could lead to the wrong carboplatin dose. All clinical labs in the U.S. will soon be using a newly standardized method to measure serum creatinine -- Isotope Di...Dec 31, 2010 - The FDA has issued an update on its continuing investigation of excessive radiation exposure from CT brain perfusion scans, including expanded recommendations for radiology personnel performing these procedures. FDA is now aware of 385 patients ...Dec 31, 2010 - The labeling for Gonadotropin-Releasing Hormone (GnRH) agonists is being updated to describe an increased risk of diabetes and certain cardiovascular diseases in patients being treated for prostate cancer. GnRH agonists are sold under a variety of b...Dec 31, 2010 - FDA is notifying healthcare professionals about updated pediatric dosing recommendations for Valcyte oral tablets and solution. Valcyte is an antiviral medication used to prevent cytomegalovirus (CMV) disease in pediatric patients who have undergone ...Dec 31, 2010 - An FDA article in the journal Nursing2009 describes problems that can arise with the use alarms on patient monitoring equipment. From 2005 through 2008, FDA received 566 reports of patient deaths related to the alarms on monitoring devices. Part of ...Dec 31, 2010 - Resectoscopes are devices used to remove tissue during endoscopy procedures. Unless they are assembled properly before each procedure, these devices can fail. For example, FDA has a report about a 2-month-old infant undergoing cystoscopy to incise ...Dec 31, 2010 - FDA is warning people not to use Hyland's Teething Tablets because they may pose a risk to babies and children. The product, which is being recalled by the manufacturer, is intended to temporarily relieve a child's teething symptoms. Hyland's Te...
- Recalls (Drug & Food)
Dole Fresh Vegetables Announces Allergy Alert and Voluntary Limited Recall of DOLE-branded Spinach ...Aug 28, 2014 - Although no illnesses or allergic reactions have been reported, Dole Fresh Vegetables is initiating a limited voluntary recall of the following products: This recall is due to possible contamination of these products by walnuts.Mars Petcare US Announces Voluntary Recall of 22 Bags of PEDIGREE Brand Adult Complete Nutrition fo...Aug 27, 2014 - Today, Mars Petcare US announced a voluntary recall of 22 bags of PEDIGREE® Adult Complete Nutrition dry dog food products due to the possible presence of a foreign material. The bags were produced in one manufacturing facility, and shipped to one retail customerAug 27, 2014 - 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.Voluntary Recall Notice of Margaret Holmes 14.5 oz Turnip Greens and 14.5 oz Mixed Greens Due to Qu...Aug 27, 2014 - McCall Farms Incorporated is initiating a voluntary recall on 14.5 oz Margaret Holmes Turnip Greens and 14.5 oz Margaret Holmes Mixed Greens due to the potential of questionable seals. This recall does not impact any other Margaret Holmes vegetables.Aug 25, 2014 - On June 3rd, 2014 Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion.Nestl Prepared Foods Company Announces Allergy Alert and Voluntary Recall Of LEAN CUISINE Culinary ...Aug 22, 2014 - Nestlé Prepared Foods Company, a business unit of Nestlé USA, is initiating the voluntary recall of a limited quantity of LEAN CUISINE® Culinary Collection Chicken with Peanut Sauce/UPC code 13800 10154 because it may contain undeclared shrimp.Aug 20, 2014 - 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.nSPIRED Natural Foods, Inc. Voluntarily Recalls Certain Retail Lots Of Arrowhead Mills Peanut Butte...Aug 19, 2014 - 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.Aug 14, 2014 - 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.Amgen Issues Voluntary Recall of Aranesp (darbepoetin alfa) (500 mcg) Prefilled Syringes in Several...Aug 14, 2014 - Amgen (NASDAQ:AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of AranespÂ® (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 Presenc...Aug 14, 2014 - 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.Baxter Initiates Voluntary Recall of One Lot of 0.9% Sodium Chloride Injection, USP Intravenous (IV...Aug 13, 2014 - 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.Aug 12, 2014 - 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.Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Nine Lots of CUBICIN (daptomycin for i...Aug 9, 2014 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.Regeneca Worldwide, A Division Of Vivaceuticals, Inc Voluntarily Recalls RegeneSlim Appetite Contro...Aug 7, 2014 - Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is conducting a voluntary nationwide recall of its RegeneSlim appetite control dietary supplement from lot # EX0616R15814 and lot #11414RE5516 because FDA analysis confirmed the presence of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.Cubist Pharmaceuticals Issues Voluntary U.S. Recall Of Certain Lots Of CUBICIN (Daptomycin For Inje...Aug 7, 2014 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling certain lots of CUBICIN® (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. Please click here for the list of affected CUBICIN lot information.Seoul Shik Poom Inc. Issues Allergy Alert on Undeclared Eggs in Choripdong Chocolate Almond Richmon...Aug 5, 2014 - Seoul Shik Poom Inc. of Englewood, NJ is recalling Choripdong Chocolate Almond Richmond Ice Bar (4bags/432ml) because they may contain undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.Aug 4, 2014 - Oasis Brands, Inc of Miami, FL is recalling Quesito Casero 12oz with expiration date 09/27/14, 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.Ortho Molecular Products Issues Allergy Alert On Undeclared Milk In Lifecore Chocolate And Lifecore...Aug 4, 2014 - Ortho Molecular Products of Stevens Point, Wisconsin is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk. According to food safety standards, people who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.New England Greens, LLC dba Vibrant Health Recalls Green Vibrance and Rainbow Vibrance Because of P...Aug 1, 2014 - New England Greens of Canaan, Connecticut is recalling 10 lots of Green Vibrance and one lot of Rainbow Vibrance after a former raw material supplier, Raw Deal of Allamuchy, NJ, recalled the Organic Parsley Leaf Powder used to manufacture Green Vibrance and Rainbow Vibrance because of the potential for contamination with Salmonella. Although the possibility is slight that any amount of Salmonella is present in any of the recalled lots of the above-mentioned products, New England Greens is issuing the recall with an abundance of caution for the safety of its consumers.
- Consumer Health Info
Aug 28, 2014 - As scientists learn more about psoriasis, more therapeutic options are becoming available for patients with this skin disease. Understanding how psoriasis develops enables them to target different steps in the disease pathway to broaden the types of treatments available.Aug 27, 2014 - Whether your child is an athlete who needs extra calories for that after-school game, or a teenager trying to maintain a healthy weight, here are four tips for making a nutritious lunch.Aug 26, 2014 - Had an issue with a medicine, medical device, or food product and did not know who to notify? FDA's MedWatch is here to help.Aug 25, 2014 - Some companies are marketing untested, unproven, and possibly dangerous products that claim to prevent, treat, or cure concussions and other traumatic brain injuries.Aug 19, 2014 - FDA warns consumers to avoid a weight loss supplement that contains undeclared drug ingredients; lack of sterility and particles in an anesthetic.Aug 15, 2014 - What is lupin, and why should you care: The answers to these two questions could have an important impact on your health.Aug 7, 2014 - Contaminated tattoo ink can cause potentially serious infections. After investigating a multi-state outbreak, FDA offers strategies for controlling your risk.Aug 6, 2014 - Kids can benefit from wearing contacts, but these lenses can cause serious eye injuries if not used and treated properly. There are issues parents should consider and, if the decision is to go with contacts, specific hygiene and safety advice to follow.Aug 6, 2014 - This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.Aug 5, 2014 - In the quest for youthful looks, both men and women are seeking treatments to minimize laugh lines and other wrinkles. Learn about a popular treatment that involves injecting dermal fillers into the face, its benefits and risks.Aug 5, 2014 - In August 2013, the Food and Drug Administration issued a final rule that defined what characteristics a food must have to bear a label that says "gluten-free." After a year, companies must now comply with the rule.Aug 4, 2014 - As the school year gets underway, parents and teachers are focused on reducing child obesity. FDA nutrition expert Shirley Blakely, a registered dietitian, says using the Nutrition Facts and list of ingredient on prepared foods are the keys to healthy eating.Jul 31, 2014 - The recent approval of a genetic test to help doctors prescribe a drug that treats colorectal cancer is just one example of the increasing importance of companion diagnostic tests in personalized medicine to ensure the safety and effectiveness of targeted therapies.Jul 30, 2014 - The Food and Drug Administration regulates cord blood, which can be stored for personal use or donated to public cord blood banks. FDA staff explain what consumers should know about regulation and donation.Jul 28, 2014 - Advances in drug treatments approved by the Food and Drug Administration (FDA) are giving the 3.2 million Americans with chronic hepatitis C a chance at a longer, healthier life. That's welcome news for baby boomers, a generation that makes up three of four adults with the hepatitis C virus.Jul 24, 2014 - The FDA, American Optometric Association and the Entertainment Industries Council are joining forces to launch a campaign for teens and young adults on wearing decorative contact lenses safely. Two videos take clips from American Horror Story to deliver the message.Jul 14, 2014 - Juvenile arthritis is one of the most common chronic illnesses affecting children. Learn about new therapies that moderate the effects of the disease.Jul 11, 2014 - FDA warns consumers to avoid topical pain relievers when children are teething; over-the-counter acne treatment that may cause severe hypersensitivity reactions; a weight loss supplement that contains undeclared drugs, and other potential drug-associated hazards.Jul 3, 2014 - With the start of hurricane season, follow these helpful tips to be prepared when the flooding begins.Jul 2, 2014 - Outdoor barbecues are a great summer treat, but they also present a food safety challenge. Here are some food safety precautions for eating outdoors.
- News Releases
Aug 25, 2014 - A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber.Aug 20, 2014 - 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.Aug 19, 2014 - 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.Aug 15, 2014 - 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.Aug 14, 2014 - 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.Aug 14, 2014 - 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.Aug 13, 2014 - 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).Aug 12, 2014 - 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.Aug 11, 2014 - On August 8, 2014, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Eastern District of Michigan against S. Serra Cheese Company, of Clinton Township, Michigan, and its owners, Stefano Serra and Fina Serra.Aug 11, 2014 - The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.Aug 6, 2014 - The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigatio...Aug 1, 2014 - The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.Aug 1, 2014 - The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.Jul 31, 2014 - Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.Jul 31, 2014 - Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.FDA Commissioner Margaret A. Hamburgs Statement on the Surgeon Generals Call to Action to Prevent S...Jul 29, 2014 - Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun.Jul 28, 2014 - The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.Jul 24, 2014 - The U.S. Food and Drug Administration and the government of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and Federal Commission for the Protection from Sanitary Risks (COFEPRIS) signed a statement of intent forming a partnership to promote the safety of fresh and minimally processed agricultural products.Jul 23, 2014 - Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceutic...Jul 23, 2014 - The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.