Drugs, Medications & Supplements

Nov 6, 2009 - Jelly Belly Candy Company is recalling 7.5-ounce cylinder-style packages of 49 Flavors Jelly Belly jelly beans because the package is incorrectly labeled. The mislabeled packages failed to list peanut butter and peanut flour in the ingredient statement...

Nov 5, 2009 - The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif.

Nov 5, 2009 - PetSmart (NASDAQ: PETM) is voluntarily recalling two Dentley’s Beef Hoof products for potential salmonella contamination. The products were manufactured by Pet Carousel, Inc. in Sanger, Calif.

Nov 4, 2009 - Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label.

Nov 4, 2009 - Charleston Cookie Company of Charleston, SC is recalling packages of Almond Cookies which were sold as a component of the Dean and Deluca "Americana" cookie tin because the cookies contain undeclared butter (milk).

Nov 3, 2009 - American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL: NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization.

Nov 3, 2009 - Pelican Bay Ltd. of Dunedin, Florida is recalling all their Caramel Chocolate Truffle Hot Chocolate Mix because it may contain undeclared tree nuts. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Nov 3, 2009 - As part of its ongoing cooperation with the Food and Drug Administration (“FDA”), Bodybuilding.com, LLC (the “Company”) announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products (the “Recalled Products”) described on the attached list, that were sold through the Company’s website, www.bodybuilding.com.

Oct 31, 2009 - Morningstar Foods is voluntarily recalling 32-ounce Great Value Half & Half, UPC 6 05388 187 16 1, item code 1871600, plant code 21-031; 32-ounce Great Value 36% Heavy Whipping Cream, UPC 6 05388 187 18 5, item code 1871800, plant code 21-031; 32-ounce Kroger brand 36% Heavy Whipping Cream, UPC 0 11110 438 28 7, item code 4382900, plant code 21-031; and 64-ounce Wholesome Farms Chocolate Ice Cream Mix, UPC 0 74865 57 983 4 (if purchased in a multi-pack, the UPC code is 1 00 74865 57983 1), item code 5798300, plant code 21-031 because these products may contain soy protein.

Oct 31, 2009 - Today, Alexia Foods, Inc, Kennewick, WA, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling packages of its Alexia – Olive Oil, Sun-Dried Tomatoes & Pesto Oven Reds (frozen seasoned potato wedges) for an undeclared allergen, pine nuts. People who have an allergy or severe sensitivity to pine nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Oct 31, 2009 - Pointe Scientific, Inc, Canton, MI is initiating a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Oct 30, 2009 - Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Oct 30, 2009 - Cordis Corporation announced today a nationwide voluntary recall of all lots of the CROSSOVER™ Sheath Introducer due to complaints about stretching or fracture of the sheath during use. The CROSSOVER™ Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids

Oct 30, 2009 - Pointe Scientific, Inc, Canton, MI is initiating a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Oct 29, 2009 - Mrs. Rios Corn Products in San Angelo, Texas is recalling its flour tortillas because they may contain undeclared Whey. People who have an allergy or severe sensitivity to Whey run the risk of serious or life-threatening allergic reaction if they consume these products.

Oct 28, 2009 - These products may contain undeclared whey (milk). People who have an allergy or severe sensitivity to whey (milk) run the risk of serious or life-threatening allergic reaction if they consume these products.

Oct 27, 2009 - Huntsville AL-Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21, 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.

Oct 27, 2009 - San Link Inc at 54B Marjorie Street Staten Island, NY 10309 is recalling Vacuum Pack Dried Lesh (fish) because the product was found to be uneviscerated.

Oct 27, 2009 - San Link Inc at 54B Marjorie Street Staten Island, NY 10309 is recalling Vacuum Pack Dried Krasnoperka (fish) because the product was found to be uneviscerated.

Oct 26, 2009 - Today, Mars Snackfood US announced a voluntary recall of its Dove Caramel Pecan Perfection ice cream with the lot number 931AB5YN07 because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. No related illnesses have been reported to date.

Nov 6, 2009 - A new program aims to reduce unnecessary injuries from medication misuse, errors, and other problems.

Nov 4, 2009 - FDA has issued recent safety alerts on these medical products.

Nov 3, 2009 - FDA and WebMD have expanded their unique partnership to provide increased access to FDA’s consumer health information.

Nov 2, 2009 - The posting of FDA staff in overseas regions is a key part of the agency's strategy for expanding oversight of imported food and medical products.

Oct 30, 2009 - As Halloween approaches, FDA reminds consumers that non-prescription decorative contact lenses may harm their vision.

Oct 28, 2009 - This Consumer Update video highlights FDA’s involvement in product recalls from the moment the agency is notified to successful completion of the recall.

Oct 28, 2009 - FDA reminds people, in time for Halloween, that non-prescription decorative contact lenses may harm their vision.

Oct 27, 2009 - FDA has stepped up its campaign to inform consumers of—and protect them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the H1N1 flu virus.

Oct 27, 2009 - Medical X-rays are an important tool for diagnosing and treating diseases, but they pose a small risk from radiation. This FDA Consumer Update video includes information on what you can do to reduce the risk.

Oct 23, 2009 - A federal, state, and industry cooperative program helps protect the public from contaminated shellfish.

Oct 23, 2009 - FDA recently issued guidelines on important differences between hearing aides and personal sound amplifying devices.

Oct 23, 2009 - FDA launches a new Web site that focuses on hearing aids.

Oct 22, 2009 - On October 15, 2009, the U.S. Food and Drug Administration (FDA) launched a study of the impact of LASIK on patients' quality of life, and issued warning letters to 17 LASIK surgery centers that release patients the same day as their surgery.

Oct 14, 2009 - Be careful about the three main types of interactions: drugs with food and beverages, drugs with dietary supplements, and drugs with other drugs.

Oct 14, 2009 - Taking the wrong medication or the wrong dose can be an easy mistake to make. It can also be life threatening. This Consumer Update video provides tips on avoiding medication mistakes.

Oct 14, 2009 - A federal, state, and industry cooperative program helps protect the public from contaminated shellfish.

Oct 2, 2009 - FDA and more than 3,000 state, local, tribal, and territorial organizations work cooperatively to protect the nation’s food supply.

Sep 30, 2009 - FDA has issued recent safety alerts on these medical products.

Sep 30, 2009 - Although most people get all the vitamins they need from the foods they eat, millions of people take supplemental vitamins as part of their health regimen. Here are facts about vitamins, including information on how they are regulated.

Sep 30, 2009 - This video highlights how FDA is working to ensure that allergens in food are clearly and accurately labeled.

Nov 6, 2009 - The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.

Nov 5, 2009 - The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif.

Nov 5, 2009 - A joint public meeting focused on improving the system for tracing of food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers was announced today by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA).

Nov 5, 2009 - The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.

Nov 4, 2009 - The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.

Nov 3, 2009 - A Virginia doctor was sentenced in federal court on charges that he wrote prescriptions over the Internet for people whom he had never met or examined, as well as tax evasion.

Nov 2, 2009 - The U.S. Food and Drug Administration and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) have sent a team of seafood specialists to Bangladesh this week to help train local officials on aquaculture safety and quality control techniques.

Nov 2, 2009 - The U.S. Food and Drug Administration (FDA) today released a listing of eight recent consumer health information updates concerning the safety of FDA-regulated products.

Nov 2, 2009 - The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sibelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests.

Nov 2, 2009 - The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009.

Nov 2, 2009 - The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

Oct 30, 2009 - The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

Oct 29, 2009 - XIN HE, aka FAITH HE, 46, of Issaquah, Washington, was found guilty today in U.S. District Court in Seattle of a felony count of Misbranding of a Drug While Held for Sale and two misdemeanor counts of Receipt & Proffered Delivery of Adulterated Device. HE was ordered into immediate custody by U.S. District Judge Marsha J. Pechman after she rendered her verdict.

Oct 29, 2009 - Jeffrey H. Sloman, Acting United States Attorney for the Southern District of Florida, David Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations, Daniel W. Auer, Special Agent in Charge, Internal Revenue Service, Criminal Investigation Division, and Henry Gutierrez, Postal Inspector in Charge, U.S. Postal Inspection Service, announce that late yesterday afternoon, a federal jury convicted defendant Frank Sarcona, a/k/a Frank Sarcone, a/k/a Dave Johnson, 57, of Boca Raton, FL, of conspiracy to commit mail, wire fraud, and criminal contempt of court; conspiracy to commit money laundering; and multiple counts of substantive mail fraud, wire fraud, money laundering, misbranding of a food, and criminal contempt of court. Sentencing has been scheduled for January 15, 2010 at 9:00 a.m. before U.S. District Court Judge Kenneth A. Marra.

Oct 29, 2009 - The U.S. Food and Drug Administration and WebMD Health Corp. today announced an expansion of their partnership to provide increased access to FDA’s consumer health information. This second phase of the partnership includes expanded content and multimedia tools at www.webmd.com/fda. WebMD is personalizing FDA health information for consumers with five new online FDA sections that will initially focus on allergies and asthma, children’s health, diabetes, heart health and vitamins and supplements.

Oct 28, 2009 - Stryker Biotech, LLC, a corporation based in Hopkinton, Massachusetts, and its former president, Mark Philip of Lexington, Massachusetts, and its current sales managers, William Heppner of Illinios, David Ard of California, and Jeff Whitaker of North Carolina, were charged today in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries. Stryker Biotech and Mark Philip were also charged with making false statements to the United States Food and Drug Administration (“FDA”).

Oct 28, 2009 - A few spaces remain for the U.S. Food and Drug Administration’s Second Annual Science Writers Symposium on Nov. 4-5, 2009.

Oct 26, 2009 - The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Oct 23, 2009 - The U.S. Food and Drug Administration announced today that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

Oct 19, 2009 - The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.