Tag Archives: Medical device

~ FDA/USDA ~~ Alerts & Safety

U.S. Food & Drug Administration (FDA) – June 2013

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Fda
Fda (Photo credit: Wikipedia)
06/28/2013 02:25 PM EDT
June 26, 2013 – MINNEAPOLIS – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
06/28/2013 01:15 PM EDT
Miami, Florida Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine, Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
06/26/2013 09:22 PM EDT
Scenic Fruit Company of Gresham, Oregon today announced it is voluntarily recalling 5,091 cases (61,092 eight ounce bags) of Woodstock Frozen Organic Pomegranate Kernels. Based on an ongoing epidemiological and traceback investigation by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) of an illness outbreak, the kernels have the potential to be contaminated with Hepatitis A virus.
06/25/2013 09:02 PM EDT
Schenectady, NY: Price Chopper Supermarket is voluntarily recalling three varieties of Burst Cookies- Brownie, Almond and Raspberry- a frozen cookie produced by Jacqueline’s Wholesale Bakery and baked off in all of the chain’s in-store bakeries, due to the presence of milk, a known allergen, which was not declared on the ingredient label. The product is not harmful in any way to those who are not allergic to milk products.
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06/22/2013 02:24 PM EDT Beta Labs, LTD (“Beta”), dietary supplement retailer, is recalling Oxyphen XR
Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128 (hereinafter referred to as the “Products”). The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.
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06/21/2013 01:58 PM EDT
Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling a limited quantity of Black Forest Ham and Cheese on a Pretzel Roll with Swiss Cheese and Country Dijon Honey Mustard because they have the potential of containing an undeclared tree nut allergen. People who have severe sensitivity or allergies to tree nuts may run the risk of a serious or life threatening allergic reaction if they consume these products.
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06/19/2013 05:27 PM EDT
Holtsville, NY, Advance Pharmaceutical Inc. today announced that this firm is conducting a voluntary nationwide recall to the user level of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually containing Acetaminophen 500 mg tablets
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06/19/2013 05:24 PM EDT
Garden-Fresh Foods Inc. is voluntarily recalling a limited number of packages of Archer Farms Smoked Salmon Dip that may contain undeclared allergens, fish and egg. Some of Archer Farms Smoked Salmon Dip may have inadvertently been filled in a limited amount of Bacon Parmesan Dip containers.
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06/18/2013 06:54 PM EDT
OSKRI Corp. of Lake Mills, WI is recalling “Coconut Bar Dark Chocolate”, “Coconut Bar Dark Chocolate Minis”, “Fig Dark Chocolate Bars” and “Almond Dark Chocolate Bars” because the dark chocolate contains milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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06/18/2013 01:58 PM EDT
Natura Pet Products is voluntarily recalling specific lots of dry pet food because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
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06/14/2013 09:16 PM EDT
See’s Company of San Francisco is recalling all Milk and Dark Raisins because it may contain undeclared tree nuts and eggs. People who have an allergy or severe sensitivity to tree nuts (e.g.: almonds, walnuts, pecans, cashews) and/or eggs run the risk of serious or life-threatening allergic reaction if they consume these products
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06/14/2013 08:13 PM EDT
OSKRI Corp. of Lake Mills, WI is recalling “Coconut Bar Dark Chocolate”, “Coconut Bar Dark Chocolate Minis”, “Fig Dark Chocolate Bars” and “Almond Dark Chocolate Bars” because the dark chocolate contains milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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06/14/2013 09:57 AM EDT
Lipari Foods of Warren, MI is recalling Raw Sunflower Seeds, Roasted Sunflower Seeds and Snack Mixes, 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.
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06/13/2013 09:04 PM EDT
Sequel Naturals Ltd. Dba “Vega” is voluntarily recalling a limited quantity of nutrition bars due to finding trace amounts of milk in some lot codes
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What does $700 million get you?


Union of Concerned Scientists

What are pharmaceutical, biotech, and medical device companies trying to buy with $700,000,000? Massive influence with our government.

Don’t allow science to take a back seat to the financial interests of corporations! Urge the FDA to protect the American people from unsafe food, drugs, and medical devices by protecting science from corporate interference.

click here to take action

That’s the amount of money these companies spent over the last three years lobbying Congress and the Executive Branch, which includes the Food and Drug Administration (FDA). And now, with negotiations underway on legislation that will govern how the FDA approves and monitors prescription drugs and medical products, it’s clear that all that money has bought the industry a lot of influence with our legislators.

We can’t allow science to take a back seat to the financial interests of corporations—especially when our lives are on the line.
We have seen many concerted efforts from industry lobbyists to roll back key safeguards at the FDA that protect science from corporate interference. The FDA’s foremost priority is to protect the American people from unsafe food, drugs, and medical devices. That requires the agency use the best available science when determining whether products are safe or not.

It’s time we remind the FDA to put safety first.
Take Action Today!

Sincerely, Michael Halpern Michael Halpern Program Manager UCS Scientific Integrity Program
P.S. Don’t Forget: Give to the Union of Concerned Scientists today and your gift will go twice as far—helping to challenge attacks on science and stand up to corporate-sponsored misinformation.

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Tell Congress to fix … The medical-device safety bill

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Today's consumer action:

Fix the Flaw!The medical-device safety bill is coming up for a major vote, and it still has a gaping loophole! Tell your Senators to Fix the Flaw!Take action

You wouldn’t buy a new car with a known safety defect. You’d expect the problem to be fixed first.

So why is Congress planning to let medical device manufacturers keep selling implants – from hip replacements to heart defibrillators to surgical mesh – without having them fix the safety flaw first?

Tell your Senators and Representative: Fix the Flaw!

This week the Senate could vote on the bill that sets safety standards for the medical device industry. Lobbyists have managed to keep this gaping safety loophole from being fixed in the bill, and we need consumers to speak out today before it’s too late.

Manufacturers love the loophole because they can put an implant on the market just by showing that it’s ‘substantially equivalent’ to one already approved – even if the implant they’re modeling it on was recalled for safety problems! And the FDA can’t make the company prove they’ve fixed the flaw or do clinical safety testing before the device is sold to you!

The consequences are serious. Tens of thousands of women have various vaginal mesh implants inside them based on a 1999 recalled product. Last year the FDA warned about bleeding, infections and organ perforation from the mesh deteriorating, and many women require multiple surgeries to repair the damage. The FDA should have the authority to demand flaws like these be fixed before allowing the devices to be sold.

Congress: Fix the Flaw with medical devices, and hold industry responsible for safety!

It’s important you get your Senators’ attention on this matter, or the loophole might just slip quietly through. Consumers’ emails have already made the safety bills stronger, so please forward this to others so they can add their voice to this critical issue.

Sincerely,
Lisa McGiffert, SafePatientProject.org

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Pesticides are killing bees

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Pesticides are killing bees and threatening our food supply. In 24 hours, shareholders at the biggest chemical producer, Bayer, could vote to stop their toxic production. Massive public pressure has forced this debate at their Annual General Meeting, now let’s make sure they vote to stop the pesticides and save the bees. Sign the emergency petition:

 

Quietly, globally, billions of bees are dying, threatening our crops and food. But if Bayer stops selling one group of pesticides, we could save bees from extinction.

Four European countries have begun banning these poisons, and some bee populations are already recovering. But Bayer, the largest producer of neonicotinoids, has lobbied hard to keep them on the market. Now, massive global pressure from Avaaz and others has forced them to consider the facts — and in 24 hours, Bayer shareholders will vote on a motion that could stop these toxic chemicals. Let’s all act now and shame the shareholders to stop killing bees.

The pressure is working, and this is our best chance to save the bees. Sign the urgent petition and send this to everyone — let’s reach half a million signers and deliver it directly to shareholders tomorrow in Germany!

http://www.avaaz.org/en/bayer_save_the_bees/?vl

Bees don’t just make honey, they are vital to life on earth, every year pollinating 90% of plants and crops — with an estimated $40bn value, over one-third of the food supply in many countries. Without immediate action to save bees, many of our favourite fruits, vegetables, and nuts could vanish from our shelves.

Recent years have seen a steep and disturbing global decline in bee populations — some bee species are already extinct and some US species are at just 4% of their previous numbers. Scientists have been scrambling for answers. Some studies claim the decline may be due to a combination of factors including disease, habitat loss and toxic chemicals. But increasingly, independent research has produced strong evidence blaming neonicotinoid pesticides. France, Italy, Slovenia and even Germany, where the main manufacturer Bayer is based, have banned one of these bee killers. But, Bayer continues to export its poison across the world.

This issue is now coming to the boil as major new studies have confirmed the scale of this problem. If we can get Bayer shareholders to act, we could shut down once and for all Bayer’s influence on policy-makers and scientists. The real experts — the beekeepers and farmers — want these deadly pesticides prohibited until and unless we have solid, independent studies that show they are safe. Let’s support them now. Sign the urgent petition to Bayer shareholders now, then forward this email:

http://www.avaaz.org/en/bayer_save_the_bees/?vl

We can no longer leave our delicate food chain in the hands of research run by the chemical companies and the regulators that are in their pockets. Banning this pesticide will move us closer to a world safe for ourselves and the other species we care about and depend on.

With hope,

Alice, Antonia, Mia, Luis, Ricken, Stephanie, Pascal, Iain, Ari and the whole Avaaz team

MORE INFORMATION

Studies fault Bayer in bee die-off (Christian Science Monitor) http://www.csmonitor.com/Science/2012/0406/Studies-fault-Bayer-in-bee-die-off

2 Studies Point to Common Pesticide as a Culprit in Declining Bee Colonies (New York Times) http://www.nytimes.com/2012/03/30/science/neocotinoid-pesticides-play-a-role-in-bees-decline-2-studies-find.html?_r=1

Leaked document shows EPA allowed bee-toxic pesticide despite own scientists’ red flags (Grist) http://grist.org/politics/food-2010-12-10-leaked-documents-show-epa-allowed-bee-toxic-pesticide/

Bayer’s Annual Stockholder’s Meeting (ASM website) http://www.asm2012.bayer.com/en/counter-motions.aspx