Drugs, Medications & Supplements

Feb 9, 2010 - Acacia, Inc. (formally known as MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company).

Feb 9, 2010 - Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation.

Feb 9, 2010 - Turkey Hill Dairy of Conestoga, Pa., is recalling its 1.5 qt. (48 oz./1.42L) packages of Chocolate Marshmallow Premium Ice Cream because the product may contain almonds that were inadvertently added during production.

Feb 9, 2010 - BD (Becton, Dickinson and Company) (NYSE:BDX) has voluntarily executed a product recall of certain lots ofBD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

Feb 5, 2010 - Cousins Products, LLC, of Covington, LA is voluntarily recalling the following Spinach Vinaigrette in 16 oz. jars

Feb 4, 2010 - Haifa Smoked Fish, located in Queens, New York, is recalling Haifa brand vacuum packaged Whole Schmaltz Herring with the lot number 20, because the product was found to be uneviscerated.

Feb 3, 2010 - Pierino Frozen Foods Inc. of Lincoln Park, Michigan is recalling its 24 oz. packages of Pierino Frozen Foods’ “Jumbo Shells with Cheese” because they 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 these products.

Feb 2, 2010 - Global Commodities Inc. of Hicksville, NY is recalling its 0.50 lbs. packages of Aahu Barah brand Dry Apricot food treats because they contain undeclared Sulfites. People who have allergies to Sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

Jan 28, 2010 - Plastic centrifuge rotor may crack, break apart and be forcefully ejected.

Jan 26, 2010 - Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted.

Jan 26, 2010 - The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Jan 22, 2010 - Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12- 24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the potential to break apart resulting in pieces of the rotor to be forcefully ejected through the plastic centrifuge housing.

Jan 22, 2010 - Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe.

Jan 21, 2010 - The Wisconsin Cheeseman® announced today that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010. Parkers Farm, Inc., located in Coon Rapids, Minnesota, believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria

Jan 15, 2010 - Hines Nut Company has initiated a recall of 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella.

Jan 15, 2010 - MuscleMaster.com, Inc. (“MuscleMaster.com”) announced today that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products"). FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol."

Jan 15, 2010 - PARKERS FARM, INC. OF COON RAPIDS, MINNESOTA TODAY EXPANDED THE PREVIOUSLY ANNOUNCED RECALL OF PRODUCTS TO INCLUDE ALL DATE CODES BECAUSE THEY HAVE THE POTENTIAL TO BE CONTAMINATED WITH LISTERIA MONOCYTOGENES, AN ORGANISM WHICH CAN CAUSE SERIOUS AND SOMETIMES FATAL INFECTION IN YOUNG CHILDREN, FRAIL OR ELDERLY PEOPLE, AND OTHERS WITH WEAKENED IMMUNE SYSTEMS. ALTHOUGH HEALTHY INDIVIDUALS MAY SUFFER ONLY SHORT-TERM SYMPOTMS SUCH AS HIGH FEVER, SEVERE HEADACHE, STIFFNESS, NAUSEA, ABDOMINAL PAIN AND DIARRHEA, LISTERIA INFECTION CAN CAUSE MISCARRIAGES AND STILLBIRTHS AMONG PREGNANT WOMEN.

Jan 15, 2010 - PEO Chapter FO of Ashland, Oregon is recalling 75 - 1 lb packages of roasted hazelnuts, because they have the potential to be contaminated with Salmonella. Salmonella is 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.

Jan 15, 2010 - In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is voluntarily recalling certain lots of OTC products in the Americas, the United Arab Emirates (UAE), and Fiji (FULL RECALLED PRODUCT LIST BELOW). The company is initiating this recall following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events. These include nausea, stomach pain, vomiting, or diarrhea.

Jan 14, 2010 - The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of “Best By 111911” because the product may be contaminated with Salmonella.

Feb 6, 2010 - FDA has issued recent safety alerts on these products.

Feb 6, 2010 - Eating healthily can help reduce your risk for the number one killer in the United States—heart disease.

Feb 6, 2010 - 将美国食品药物管理局人员派往某些海外地区的分支机构是该局扩大对进口食品和药品监督策略的一个重要部分。

Feb 6, 2010 - La mutation des membres de son personnel dans certaines régions à l’étranger est un facteur majeur de sa stratégie pour intensifier la surveillance des aliments et des produits médicaux importés.

Feb 6, 2010 - Los puestos del personal de la FDA en ciertas regiones extranjeras son una parte clave que la agencia tiene como estrategia para expandir la supervisión de los productos alimenticios y médicos importados.

Feb 6, 2010 - Numerous smoking cessation products have FDA approval. It's important to know the benefits, potential side effects, and risks associated with these products as you decide whether to use them.

Feb 6, 2010 - FDA warns of counterfeit weight-loss drug Alli 60 mg capsules (120 count refill pack) sold over the Internet.

Feb 6, 2010 - FDA has launched “FDA Basics” on its Web site to help the public better understand what the agency does.

Feb 6, 2010 - FDA has issued recent safety alerts on these products.

Feb 6, 2010 - A look at various causes of memory loss and treatment approaches.

Feb 6, 2010 - Learn how to spot health fraud and avoid it with this FDA Consumer Update video.

Feb 6, 2010 - FDA has issued a notification for health professionals and advice for patients, linked to reports of rare but serious complications, including deaths, arising from use of negative pressure wound therapy.

Feb 6, 2010 - FDA has issued recent safety alerts on these medical products.

Feb 6, 2010 - There’s no such thing as a safe tan. Whether from the sun or from sunlamps used in tanning equipment, ultraviolet rays pose a health risk.

Feb 6, 2010 - Los consumidores tienen una función que cumplir, sobre todo cuando manipulan los alimentos en el hogar.

Feb 6, 2010 - FDA gives consumers practical food safety tips to help prevent foodborne illness

Feb 6, 2010 - In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.

Feb 6, 2010 - FDA expands its reach to millions of consumers through a new partnership with Everyday Health.

Feb 6, 2010 - Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.

Feb 6, 2010 - A new program aims to reduce unnecessary injuries from medication misuse, errors, and other problems.

Feb 9, 2010 - On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it. The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

Feb 9, 2010 - The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

Feb 5, 2010 - The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

Feb 4, 2010 - The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

Feb 3, 2010 - At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.

Feb 3, 2010 - The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.

Feb 1, 2010 - The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.

Feb 1, 2010 - The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine). Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

Feb 1, 2010 - The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world. PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health. The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.

Jan 29, 2010 - The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.

Jan 29, 2010 - The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

Jan 29, 2010 - At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

Jan 26, 2010 - The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Jan 26, 2010 - The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

Jan 25, 2010 - The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

Jan 25, 2010 - The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

Jan 22, 2010 - The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

Jan 22, 2010 - The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.

Jan 20, 2010 - The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

Jan 19, 2010 - According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for wrinkle removal such as Botox and Restylane.