The complaint, filed on March 16, 2010, in the U.S. District Court for the Eastern District of Louisiana, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by preparing, packing, and holding sprouts under insanitary conditions, where they may have become contaminated with filth.

“The agency has repeatedly warned the company over several years that corrective actions need to be taken in this facility,” said Michael Chappell, acting associate commissioner for regulatory affairs at the FDA. “While no illnesses have been reported to date, this action is necessary to ensure that it remains that way.”

The ready-to-eat sprouts are distributed to wholesale suppliers, who in turn distribute them to customers located in Gulf Coast states, including Louisiana, Mississippi, Alabama, Florida, and Texas.

Five FDA inspections over the past nine years, including an inspection conducted between August 2009 and September 2009, revealed that the defendants failed to implement basic food sanitation principles and practices for their sprout growing operation, according to the complaint.

The complaint alleges violations that include equipment and facilities that were unclean or unable to be sufficiently cleaned, insanitary employee practices, and a poorly maintained facility.

Source: U.S. Food and Drug Administration

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CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.

However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.

For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.

Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.

“Working together,” said Shuren, “the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose.”

The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.

In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.

The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.

A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.

In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.

Source: U.S. Food and Drug Administration

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The penalty settlement which has been provisionally accepted by the Commission, resolves staff allegations that the company violated the federal lead paint ban regarding toys with surface paints containing lead above the 600 parts per million (ppm) legal limit applicable at the time, and failed to immediately report to CPSC information about the non-compliant toys.
In 1978, a federal ban was established that prohibited toys and other children’s articles from having more than 600 ppm (by weight) in paints or surface coatings. The regulatory limit was reduced to 90 ppm on August 14, 2009, as a result of the Consumer Product Safety Improvement Act of 2008.

The settlement resolves the following allegations:

* Schylling imported up to 66,000 units of non-compliant spinning top toys with Thomas and Friends, Curious George and Circus graphics between June 2001 and June 2002, and distributed them to its retail business customers for sale to consumers.

* Schylling imported as many as 10,200 units of non-compliant tin pail toys with Thomas and Friends, Curious George and Primary Colors graphics from late January 2002 through March 2002, and distributed about 4,700 of them to its retail customers for sale to consumers.

* Schylling also imported as many as 3,600 units of non-compliant Winnie-the-Pooh style spinning top toys between April and May 2003, and distributed them to its retail customers for sale to consumers.

* Although it eventually reported about these toys to CPSC in 2007, Schylling knew or should have known by 2002 that most of the toys did not comply with the lead paint ban, and it failed to report this information to the government in a timely manner.

Instead of notifying CPSC immediately, in 2002 Schylling conducted a unilateral recall of the distributed pails by seeking their return from affected retail business customers.

Within weeks of being notified of each of these violations in 2007, CPSC announced the firm’s voluntary recall of the products first in August and for additional toys in November of that year.

“Manufacturers, importers, distributors and retailers have a legal obligation to ensure that no banned products are introduced into or distributed in the U.S. marketplace, and to inform CPSC as soon as they become aware of information that must be reported under our laws. We will continue to penalize companies that do not follow these basic requirements,” said CPSC Chairman, Inez Tenenbaum.

In agreeing to the settlement, Schylling denies that it violated federal law, as alleged by CPSC staff.

Source: CPSC

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During an FDA inspection of Mid-States Closeouts conducted in November and December 2009, the agency found widespread and active rodent infestation, numerous gnawed packages of human and animal food, rodent excreta pellets on, in, and around food packages and rodent nesting material. The facility also had structural defects permitting easy pest access to the entire facility, and rodent harborage areas near the warehouse.

“The violations at Mid-States Closeouts are widespread and significant,” said Michael Chappell, the FDA’s acting associate commissioner, Office of Regulatory Affairs. “The FDA took this action because the company failed to provide adequate safeguards to ensure that products they hold for sale remain free of contamination.”

The FDA has not received any reports of human or pet illness or death associated with consumption of food distributed by Mid-States Closeouts. However, the seized products were in permeable packages and held under conditions that could compromise the food’s quality.

Source: U.S. Food and Drug Administration

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Teamwork will be the key to everyone enjoying a healthy experience at the Olympic and Paralympic games. You can help in the fight to control the flu’s spread by remembering to “Stop, Wash and Go:”

* Stop: Make sure you feel well before traveling. If you have the flu or have flu-like symptoms, delay your travel plans until your fever has been gone for at least 24 hours without the use of fever-reducing medicines.
* Wash: Help prevent the spread of the flu by covering your coughs and sneezes with a tissue or your upper sleeve and wash your hands often with soap and water.
* Go: If you are healthy and taking the appropriate precautions, go – and have a great time..

“Successful Olympic athletes will tell you it’s not enough to know the rules of the game. To win gold, they must devote themselves to training and preparing and make sure they have the right equipment,” said Dr. Gary Brunette, lead of CDC’s Traveler’s Health Branch. “It’s much the same for Olympic travelers who want to get the most out of their trip. By preparing well and taking along the necessary items for healthy travel, Olympic spectators can be sure to stay healthy and have fun.”

Before leaving for the games, talk with your doctor about how to stay healthy while traveling and whether you should get vaccinated against seasonal flu and 2009 H1N1 flu if you haven’t already received them. Contact your health insurance provider to learn the extent of your medical coverage outside the United States and consider getting travel insurance if your plan doesn’t cover international travel. Do some research before you go on flu prevention and health recommendations for travel to Canada at these Web sites: www.flu.gov and www.cdc.gov/travel.

Travelers should pack the right equipment, including a travel health kit to help keep important medications with you on your trip. Flu prevention can be travel-sized. Your kit can include alcohol-based hand sanitizer, tissues, and pain and fever medicines. You can find additional CDC recommendations for your travel health kit at http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-2/travel-health-kits.aspx. Also, be sure to take the right clothes. Dress in layers, including – if you’re outside in the damp – a waterproof outer layer. Protect your body from heat loss and cold weather with hats, scarves, and waterproof, insulated boots and gloves.

Source: CDC

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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.

During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA’s Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.

Non-cirrhotic portal hypertension occurs when blood flow in the portal vein — a major vein in the liver — slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding.

The Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.

The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people.

Videx/Videx EC is marketed by Princeton, N.J.-based Bristol-Myers Squibb.

Source: U.S. Food and Drug Administration

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The Food Animal Residue Avoidance Databank (FARAD) — used by veterinarians, livestock producers, and state and federal regulatory and extension specialists to ensure that drug, environmental and pesticide contaminants do not end up in meat, milk, and eggs — began shutting down yesterday. The program needed an immediate cash infusion to stay open, and, ultimately, long-term funding of $2.5 million per year.

The American Veterinary Medical Association (AVMA) has been leading efforts to fund FARAD, which is administered by the USDA’s Cooperative State Research, Education, and Extension Service and operates out of North Carolina State University, the University of Florida and the University of California-Davis.

Through lobbying and grassroots efforts, the AVMA worked with Congress to have language authorizing FARAD at $2.5 million inserted in this year’s Farm Bill. The USDA, however, never incorporated the funding in its budget, and Congress has provided neither emergency funding nor appropriations.

“It’s disheartening — even tragic — that a program that costs so little yet does so much to keep our food supply safe is not being funded,” said Dr. Mark Lutschaunig, director of the AVMA’s Government Relations Division. “We’re talking about a cost of less than a penny per American to help keep meat, eggs and dairy products free of drugs and pesticides.”

Lutschaunig said the last-ditch hope of keeping FARAD from completely closing is for the USDA or stakeholders to fund the program. The AVMA is planning an emergency stakeholder meeting to discuss the future of FARAD.

Source: American Veterinary Medical Association

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CPSC is issuing this safety alert because SFCA Inc., the company which purchased all of Simplicity Inc.’s assets at public auction in April 2008, has refused to cooperate with the government and recall the products. SFCA maintains that it is not responsible for products previously manufactured by Simplicity Inc.

The Simplicity 3-in-1 and 4-in-1 convertible bassinets contain metal bars spaced farther apart than 2 3/8 inches, which is the maximum distance allowed under the federal crib safety standard. The metal bars are covered by an adjustable fabric flap which is attached by velcro. The fabric is folded down when the bassinet is converted into a bed-side co-sleeping position. If the velcro is not properly re-secured when the flap is adjusted, an infant can slip through the opening and become entrapped in the metal bars and suffocate. This warning does not cover bassinets produced in recent months that have fabric permanently attached over the lower bar.

Due to the serious hazard these bassinets pose to babies, CPSC urges all consumers to share this safety warning with day care centers, consignment stores, family and friends to ensure that no child is placed to sleep in a Simplicity convertible bassinet covered by this warning.

The Commission voted, using its new authorities in the Consumer Product Safety Improvement Act, to release this warning upon making a finding that the health and safety of the public require immediate notice.

Source: CPSC

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President George W. Bush signed the Act into law which requires portable gasoline containers manufactured for sale in the U.S. on or after January 17, 2009 to conform to child resistance safety requirements.

Gasoline containers will join containers with other flammable liquids, such as turpentine, charcoal lighter fluid, and torch fuel that are required to have child resistant closures. CPSC has jurisdiction over child resistant product packaging.

“Families who purchase gasoline cans with child resistant gas caps and who keep all flammable liquids out of the sight and reach of children are improving the safety of their homes,” said CPSC Acting Chairman Nancy Nord.

CPSC recommends these safety tips for consumers.

• Buy a gasoline container that is child resistant.
• Place a gasoline container in a well ventilated, cool area.
• Never store gasoline or other fuel inside the house, in the basement, or near a fuel-burning appliance, open flames, pilot lights, stoves, heaters, electric mowers, or any other sources of ignition.
• Never smoke near gasoline.
• Never carry gasoline in the trunk of the car. Escaping vapors can easily ignite.
• Keep gasoline, kerosene and other fuels out of the reach of children. Never permit children to play with matches or fuel.

CPSC also requires child resistant packaging for many products that are dangerous for children to swallow including over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen, household cleaning products including drain openers, personal care products such as baby oil and mouthwash containing ethanol, and adult strength vitamins and supplements with iron. For aspirin and oral prescription medicine, special packaging has saved the lives of about 900 children since the early 1970s.

Source: CPSC

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The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

“Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations,” said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. “The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products.”

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be “new safety information” as defined in FDAAA.

The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients’ and prescribers’ understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.

Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Source: FDA

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