Tag Archives: Food And Drug Administration

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Paying for implants


Policy and Action from Consumer Reports

You’re stuck paying when implants fail. Really.Hip and knee manufacturers make billions marketing their products to younger and younger Americans. But they don’t back them up with a warranty, leaving  patients or taxpayers on the hook for their cost if they fail. Join our campaign to demand they warranty implants!Take action

 

 

 

 

You’ve likely seen the TV ads for knee and hip replacements. These implants are big business in America, and why not? Who doesn’t want to feel better, play longer.

But there’s something important you don’t know. Most hips and knees aren’t required by the FDA to be proven safe and effective before they’re implanted in our bodies.

And despite manufacturer claims that implants are safe and of high quality, the largest U.S. companies won’t back them up with a warranty if they fail – dumping the cost to replace them on patients or taxpayers. Really?

Join our campaign to demand implant makers warranty their products. You shouldn’t pay for their failure!

Just like the warranties that cover defects in cars and computers, artificial knees and hips should come with a guarantee so the manufacturer – not you or Medicare – pays to replace them due to a defect. Already more than a million surgeries are performed each year, and that’s expected to reach 4 million by 2030 as industry markets these joints to younger Americans.

When an implant fails, it can require complex revision surgery that can cost tens of thousands of dollars. Recently, Johnson & Johnson recalled a metal hip after one in eight patients needed it replaced within just five years. Our research found that all the major hip and knee makers have recalled a product, or line of products, in the past decade.

Without a warranty, it’s unclear who pays: the patient, the insurance company, or Medicare – which taxpayers end up covering. Only one major manufacturer has a warranty, and it’s just on one knee product. For all other hips and knees, companies aren’t on the hook for the replacement cost, despite implants ringing up billions in annual sales.

These companies make big money marketing new knees and hips to us. Demand they back their products with a warranty!

By taking action, you’ll be joining tens of thousands of other consumers sending an email directly to manufacturers’ headquarters. The more emails we can send, the more we can hold companies accountable for their products!

Sincerely, Lisa McGiffert, Consumers Union Policy and Action from Consumer Reports

~ Culture & History, ~ politics petitions pollution and pop culture

The EWG 2013 Dirty Dozen and Clean Fifteen Shoppers Guide

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The 2013 Dirty Dozen and Clean Fifteen Shoppers Guide

Can’t download it? You need the latest version of Adobe Acrobat Reader to view the guide. Get a free version of Adobe Acrobat Reader here.

by Melissa Breyer

                from Living / Green Food

                June 20, 2012

Health and environment watchdog, Environmental Working Group (EWG), has released the eighth edition of its Shopper’s Guide to Pesticides in Produce with updated data on 45 commonly-consumed fruits and vegetables and their total pesticide loads. The results are based on analysis of pesticide residue testing data from the US Department of Agriculture and Food and Drug Administration

Every year EWG takes to task the worst offenders with its Dirty Dozen list, while giving a shout-out to produce with the lowest pesticide levels with the list of the Clean Fifteen. It’s such a brilliant and helpful approach, giving shoppers the power to avoid the most contaminated food while still being able to purchase conventional produce when and if circumstances require it.

This year they also added a new category to the Dirty Dozen — the Plus category includes green beans and leafy greens (kale and collard greens) that haven’t met traditional Dirty Dozen criteria, but are found to be routinely tainted with highly toxic organophosphate insecticides. According to EWG, these insecticides are toxic to the nervous system and have been largely removed from agriculture over the past decade, but they are not banned and still show up on some food crops. Sigh.

Dirty Dozen: The 12 to buy organic (in order of pesticide load, apples being the worst offenders).

1. Apples

2. Celery

3. Sweet bell peppers

4. Peaches

5. Strawberries

6. Imported nectarines

7. Grapes

8. Spinach

9. Lettuce

10. Cucumbers

11. Domestic blueberries

12. Potatoes

Clean Fifteen: Buying organic is more sound environmentally, but if you can’t, these options are less contaminated and don’t pose as much of a health threat as do the dozen above.

1. Onions

2. Sweet corn

3. Pineapples

4. Avocado

5. Cabbage

6. Sweet peas

7. Asparagus

8. Mangoes

9. Eggplant

10. Kiwi

11. Domestic cantaloupe

12. Sweet potatoes

13. Grapefruit

14. Watermelon

15. Mushrooms

Other disheartening data from the report includes:

Some 98 percent of conventional apples have detectable levels of pesticides.Domestic blueberries tested positive for 42 different pesticide residues.Seventy-eight different pesticides were found on lettuce samples.Every single nectarine USDA tested had measurable pesticide residues.As a category, grapes have more types of pesticides than any other fruit, with 64 different chemicals.Thirteen different pesticides were measured on a single sample each of celery and strawberries.

~ FDA/USDA ~~ Alerts & Safety

US Food & Drug Administration (FDA)


English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)

 

 
05/31/2013 08:17 PM EDT
Blessings Inc. of Tucson, Arizona is voluntarily recalling its domestic 16-20 EZ Peel Shrimp because it contains the undeclared allergen sulfite above the levels required for products labeled “sulfite-free.”
 
 
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05/31/2013 11:18 PM EDT
International Desserts of Glendale, California is recalling Uncle Eddies Vegan Oatmeal Chocolate Cookies in 12 oz bags, because it may contain undeclared walnuts
 
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05/31/2013 08:29 PM EDT
This is a clarification update to the Salmolux press release announcing its voluntary recall of certain cold smoked salmon products. This update does not add to the total pounds recalled, but merely adds clarifications on description of products and one more UPC code only.
 
 
~ FDA/USDA ~~ Alerts & Safety

U.S. Food & Drug Administration (FDA)


FDA (trade union)
FDA (trade union) (Photo credit: Wikipedia)

FDAlogo

05/17/2013 09:41 AM EDT
Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.
 
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05/10/2013 04:49 PM EDT
Hannaford Supermarkets is recalling two products sold in the bakery section because they may contain nuts that are not listed on the product packaging label. Individuals who have an allergy or severe sensitivity to any nuts may run the risk of serious or life-threatening allergic reaction should they consume these items.
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05/10/2013 04:00 PM EDT
The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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05/10/2013 04:53 PM EDT
Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, 626570615316 Velextra brand SKU’s 626570613855, 626570619055, 626570617860, 626570617563 Amerect SKU’s 626570619031, 626570619628 capsules to the consumer level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.
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05/10/2013 10:09 PM EDT
May 10, 2013 – Weston, Florida: Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.
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05/10/2013 04:48 PM EDT
Smart & Final of Los Angeles, Calif., which previously announced a recall of certain production dates of 2.5 lb – La Romanella Tri-Color Cheese Tortellini, is expanding its recall to include additional production dates due to undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
 
~ FDA/USDA ~~ Alerts & Safety, ~ politics petitions pollution and pop culture

U.S. Food & Drug Administration (FDA)


FDA (trade union)
FDA (trade union) (Photo credit: Wikipedia)
05/07/2013 09:23 PM EDT
Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, Velextra brand SKU’s 626570619475, 626570619475, 626570619475, 626570619475 , Amerect SKU’s 626570619031, 626570619598 capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.

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Cargill’s Animal Nutrition Business Conducts Voluntary Recall of Lamb Feed

05/06/2013 05:25 PM EDT
Cargill’s animal nutrition business today announced a voluntary recall of Showmaster® S-Series Show Lamb Feed (BW) because it contained incorrect sodium molybdate levels. To date, there are 170, 50-pound bags of feed still out in the market.
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Medtronic Announces FDA Classification Of Deep Brain Stimulation Lead Cap Communication

05/03/2013 09:16 AM EDT
In keeping with its commitment to keep physicians informed about product performance and safety, Medtronic, Inc. (NYSE: MDT) issued an Urgent Medical Device Correction notification in February 2013 to provide physicians with information concerning the potential for deep brain stimulation (DBS) lead damage associated with the use of the lead cap provided in Medtronic DBS lead kits and dystonia therapy kits.
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05/03/2013 10:42 AM EDT
Nestlé USA’s Pizza Division today announced the voluntary recall of select production codes of four different frozen pizzas sold in the U.S. These include: • California Pizza Kitchen (CPK) Crispy Thin Crust White®, UPC 71921 98745; production codes are 3062525951, 3062525952 and 3063525951