Tag Archives: FDA

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FDA Alerts & Recalls ~~ Nov 2013


English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
11/27/2013 04:38 PM EST
Flat Creek Farm and Dairy of Swainsboro, GA has recalled 200 pounds of Heavenly Blue cheese, because of potential contamination. As of November 27, 2013 at 11:00am, according to Flat Creek records, all of the purchasers have been notified and more than 90% of the product has been collected or destroyed.

Zip International Group LLC Recalls Herring Fillet in Oil Due to Potential Health Risk

11/27/2013 10:07 AM EST
ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837, is recalling herring fillet in oil (FOSFOREL, ATLANTIKA) 400 gram in plastic packaging due to Listeria contamination.

CLR Medicals International Inc. Issues Nationwide Recall of Viscoelastic Products

11/25/2013 07:39 PM EST
CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.

Jayone Food Issues Voluntary Alert on Undeclared Peanuts in Dried Seaweed Salad

11/23/2013 09:18 PM EST
Jayone Foods, inc. of Paramount, CA is voluntarily recalling All date codes of Trader Joe’s Dried Seaweed Salad with Spicy Dressing (SKU 97677), because it may contain traces of peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

Recall expanded to include: Raspberry Lemonade OxyELITE Pro Super Thermo Powder

11/19/2013 08:44 PM EST
USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products listed below. These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.
11/19/2013 03:49 PM EST
Blount Fine Foods of Fall River, MA is recalling a single lot code of Wegman’s branded refrigerated New England Clam Chowder in 16 ounce retail cup pack size because of undeclared crab allergen. People who have an allergy or severe sensitivity to crab run the risk of suffering serious or life-threatening reactions if they consume this product.
11/18/2013 01:00 PM EST
FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
 Following FDA actions, USPLabs on Nov. 9, 2013 recalled certain OxyElite Pro dietary supplements linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants. Additionally, FDA will oversee the destruction of warehouse stocks of the supplement, with a retail value of about $22 million.
While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1. Both products contain a new dietary ingredient for which the company did not provide evidence of safety.
11/15/2013 08:59 PM EST
La Boulange Cafe & Bakery voluntarily initiated a product recall of 75 Soft Caramel Jams in 8.4 oz. jars with lot number 822713 as a precautionary measure. This product was sold exclusively in 20 La Boulange Café & Bakery stores in the San Francisco Bay Area.
11/15/2013 03:18 PM EST
S&M Enterprise of Bayonne, NJ is recalling all lots of Fruit of Wolfberry in 12 oz plastic bag packages. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
11/14/2013 11:45 PM EST
Crunch Pak of Cashmere, Washington is voluntarily recalling 5,471 cases of Crunch Pak Apple Slices due to a possible health risk from Listeria monocytogenes.
11/07/2013 10:50 AM EST
Bailey’s Choice LLC. in Waleska, GA is recalling its 5 oz. packages of chicken treats because they have the potential to be contaminated with Salmonella, 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. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
11/13/2013 04:52 PM EST
3 Fellers LLC is voluntarily initiating a product recall of 3 Fellers Chocolate Cream Pies with the UPC# 891796002732 as a precautionary measure. The recall was initiated after it was discovered by the company that the product may contain undeclared almonds.
11/12/2013 05:13 PM EST
Whole Foods Market’s Northern California region is recalling ready-to-eat Artichoke Wheatberry Salad and Southwest SooFoo®* Salad in response to a recall issued today by Glass Onion Catering. The salads are being recalled as a preventive measure because they have the potential to be contaminated with E. coli O157:h7, a bacteria that may cause illness.
11/08/2013 10:04 PM EST
Sequel Naturals Inc., dba “Vega,” announced today that it has taken the precautionary measure of voluntarily withdrawing a limited quantity of its Vega One Nutritional Shakes and Sports Performance Protein products due to finding trace amounts of chloramphenicol (CAP), a naturally occurring antibiotic. Chloramphenicol is a prescription drug commonly used to treat typhoid fever and eye infections around the world. It should only be used under medical supervision.
11/10/2013 08:27 PM EST
Athertone Foods, Inc. of Richmond, CA is voluntary recalling “Best Buy” dates 9-23-13 through 11-14-13 of ready to eat salads and wraps because they may be contaminated with Escherichia coli O157:H7 bacteria (E. coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools.
11/11/2013 01:43 PM EST
Palmer Candy Company of Sioux City, IA is recalling 102 cases of HyVee Chocolate Caramel Clusters and 90 cases HyVee Chocolate Covered Caramels because they may contain undeclared peanuts. People who have an allergy to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.
11/09/2013 03:27 PM EST
Plum Organics is voluntarily recalling pouch products within its Baby Stage 2, Tots Mish Mash and Kids lines after discovering a manufacturing defect that may cause spoilage in some pouches. Recalled products can be identified by the “Best By” dates ranging from 08/05/14 to 12/08/14 and the letters “AT.”
11/05/2013 03:59 PM EST GOURMET EXPRESS, LLC VOLUNTARILY RECALLS 32 OUNCE PACKAGES OF “FUSIA CHICKEN LO MEIN” AND 21 OZ PACKAGES OF “BREMER 3 CHEESE CHICKEN” AND “BREMER GARLIC SHRIMP SKILLET MEALS DUE TO POSSIBLE UNDECLARED. People who have allergies to egg, run the risk of serious or life-threatening allergic reaction if they consume these products
11/04/2013 01:32 PM EST
October 30, 2013 – Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products included in the expanded recall were produced between the dates of September 5, 2013 through October 16, 2013.
11/05/2013 03:59 PM EST
GOURMET EXPRESS, LLC VOLUNTARILY RECALLS 32 OUNCE PACKAGES OF “FUSIA CHICKEN LO MEIN” AND 21 OZ PACKAGES OF “BREMER 3 CHEESE CHICKEN” AND “BREMER GARLIC SHRIMP SKILLET MEALS DUE TO POSSIBLE UNDECLARED. People who have allergies to egg, run the risk of serious or life-threatening allergic reaction if they consume these products.

Teens and Steroids: A Dangerous Combo

11/04/2013 11:00 AM EST Teens are particularly at risk for adverse effects associated with anabolic steroids—possible mood swings, aggressive behavior, heart and liver disease, shrinkage of the testes in males, and menstrual irregularities in women. Ali Mohamadi, M.D., a medical officer in the Food and Drug Administration’s Division of Metabolism and Endocrinology Products, warns teens and parents about the dangers of steroid use.

11/04/2013 01:32 PM EST
October 30, 2013 – Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products included in the expanded recall were produced between the dates of September 5, 2013 through October 16, 2013.
11/04/2013 01:07 PM EST
Reser’s Fine Foods, Inc. of Beaverton, Oregon is voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes. Listeria is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems.
11/04/2013 12:33 PM EST
Ghiringhelli Specialty Foods of Vallejo, California is voluntarily recalling one specific lot of Trader Giotto’s Caesar Salad (SKU 05161) with a “Use By 11/03” date, because it may not list wheat, soy and fish (anchovy) in the ingredients. People who have an allergy or severe sensitivity to wheat, soy and/or anchovy run the risk of serious or life-threatening allergic reaction if they consume these products.
11/01/2013 05:53 PM EDT
Following the Reser’s Fine Foods (“Reser’s”) recall where select Reser’s products were recalled due to the potential of being contaminated with Listeria monocytogenes, Dutch Treat Salads, LLC, of Zeeland, MI, is voluntarily recalling one product, Mexicali Dip, that contains one ingredient recalled by Reser’s.
11/01/2013 10:18 PM EDT
The Perrigo Company (NYSE: PRGO; TASE) announced today that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under the store brand products listed below. The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings.
11/01/2013 04:07 PM EDT
Winn-Dixie today announced an immediate recall in all Winn-Dixie stores of the Taylor Farms Broccoli Crunch Salad sold in the full-service case in the deli department. According to the U.S. Food and Drug Administration, the reason for the recall is the potential that the product may be contaminated with Listeria monocytogenes. The recall is part of a larger recall issued by Taylor Farms Tennessee, Inc. and Taylor Farms Maryland, Inc. as a result of a recall of Reser’s Fine Food Inc. products.
11/01/2013 04:10 PM EDT
Winn-Dixie today announced an immediate recall of the Taylor Farms Spinach Antipasta Salad in all Winn-Dixie stores. This recall is an expansion of an earlier recall announced by Reser’s Fine Foods, Inc.
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We won! Pregnancy Discrimination Bill Is Signed Into Law
   abetterbalance.org
Dina Bakst stands behind  Mayor Bloomberg as he signs the bill into law
Dear Friend,
Today, Mayor Michael Bloomberg signed the New York City Pregnant Workers Fairness Act into law! This victory, which will have a profound impact on the health and economic well-being of NYC women and families would not have been possible without your unwavering support. This victory brings us one step closer on the road to justice and equality!
A Better Balance worked with legislators to draft the bill, which was inspired by Co-Founder & Co-President Dina Bakst’s New York Times Op-Ed. The law will ensure that pregnant women and new mothers in New York City are not pushed off the job just because they need a reasonable accommodation in order to stay healthy. Thank you for your support as we move forward in our efforts to enforce this law and strengthen pregnancy discrimination laws around the country.
With much appreciation,
The ABB Team: Sherry, Dina, Phoebe, Jared, Elizabeth, Risha, Liz, and Rachel
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$#!^@#%!


GOP Takes Obamacare Meltdown To A Whole New Level

A mere seven days remain for Congress to pass a spending bill in order to avoid a government shutdown. But Republicans are farther away than ever from agreeing to a reasonable plan that would keep the government open.

On Friday, the House GOP continued its march toward shutdown by passing a bill that ties keeping the government open to–surprise!–fully defunding Obamacare. Once again, Republicans refuse to do the hard work of actual governing in favor of playing political games that threaten to sabotage the economy. But while the vote only solidified the GOP’s ideological and dangerous strategy, it opened the floodgates for more infighting among its owns members. Here is what a number of key GOP players and establishment thinkers have to say about the “defund at all costs” plan:

  • GOP Sen. John McCain (AZ): “I can tell you that in the U.S. Senate, we will not repeal or defund Obamacare. We will not. And to think we can is not rational.”
  • GOP Strategist Karl Rove: The GOP defunding strategy is “self-defeating…It is an ill-conceived tactic, and Republicans should reject it.”
  • Fox News Host Bill O’Reilly: Defunding Obamacare is “fanaticism on the right,” O’Reilly says. “There’s no way Obamacare is going to be defunded. It’s not gonna happen.”
  • GOP Sen. Tom Coburn (OK): “Tactics and strategies ought to be based on what the real world is, and we do not have the political power to do this.”
  • GOP Sen. Rand Paul (KY): “I’m acknowledging we can’t probably defeat or get rid of Obamacare.”
  • GOP Sen. Kelly Ayotte (NH): “I don’t believe they should shut down the government to [defund Obamacare], and I don’t think that is a strategy that is good for America.”
  • GOP Sen. Johnny Isakson (GA): “It’s total atrophy. We’re earning our 11 percent popularity. It’s easier to talk about Obamacare than the major sources of our problems.”
  • Wall Street Journal Editorial Board: “Kamikaze missions rarely turn out well, least of all for the pilots… The kamikazes could end up ensuring the return of all-Democratic rule.”

Now, they all may just be trying to protect their party’s interests. But they seem to know what most Americans already do: the extreme demands by the GOP to push a narrow ideological agenda are out of touch. A new bipartisan CNBC poll released today proves that point. Almost six in ten Americans oppose defunding the health care law if it means a government shutdown, while just 19 percent support. A poll released last week found that only 23 percent of Americans want to make the health care law fail.

BOTTOM LINE: Republicans’ political games are threatening our nation’s economic recovery. Americans don’t want to shut down the government and want an end to the hostage-taking political tactics that place ideology over practical solutions for stability and growth.

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Great News for Alaska’s Bristol Bay —


September 2013 Take ActionDonate
The Big Story
Anglo American Quits the Proposed Pebble Mine
In a surprise decision that brought new hope to Alaska’s Bristol Bay, British mining giant Anglo American — the lead company behind the Pebble Mine — announced that it is abandoning the project. The announcement dealt a heavy blow to the proposed gold and copper operation, which would produce some 10 billion tons of contaminated waste and threaten the greatest wild salmon runs on the planet. NRDC Members helped make this victory possible by deluging Anglo American with nearly one million messages of protest. The fight is not over yet — we’ll need new funding to ratchet up the pressure on the remaining companies behind the mine and win EPA action to protect Bristol Bay from large-scale mining.

Pebble Mine
Campaign Updates
Navy Refuses to Protect Marine Mammals from Deadly Sonar
The U.S. Navy says it will ignore a unanimous recommendation by the California Coastal Commission to reduce the harmful effects of naval sonar on the state’s marine mammals, which would violate California law. The Navy is planning to dramatically increase its use of dangerous sonar and high-powered explosives off the coast of Southern California during training and testing. It predicts that such operations will kill hundreds of marine mammals — and injure thousands of others — over the next five years. New research shows that the Navy’s California training is already putting entire whale populations at risk, including endangered blue whales, the largest animal on Earth.
Marine Mammals
Ad of the Month
Ad of the Month
Nobel Laureates Denounce Keystone XL
NRDC and our partners ran a full-page ad in The Washington Post that featured a letter from ten Nobel Peace Prize winners, calling on President Obama to reject the Keystone XL tar sands pipeline and lead the way beyond dirty oil.
Nobel Laureates Ad
See the Ad
In the News
U.S. Blocks Import
of Wild-Caught Belugas
The National Marine Fisheries Service has denied a permit — opposed by NRDC — that would have allowed the Georgia Aquarium to import 18 wild-caught belugas from Russia for public display purposes at aquaria around the country. We applaud the decision since Russia’s wild beluga population is still recovering after being hunted nearly to extinction in the 1960s. Read more. Beluga
CA County Cracks Down
on Fracking
In July, NRDC’s Community Fracking Defense Campaign scored a big victory when California’s San Benito County approved an ordinance imposing new safeguards on this dangerous form of oil and gas extraction, including a greater setback from homes and disclosure of the chemicals used during drilling or fracking. Read more. Fracking
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Meet Carl Sciortino


Carl Sciortino, the first congressional candidate we’ve endorsed this cycle, who “comes out” as liberal to his Tea Party father in a new ad.

Over 200,000 people watched the ad so far. The election’s one month away and Carl will be on MSNBC’s Hardball tonight at 7pm!

Watch the ad everyone’s talking about — and chip in $3 to make sure Massachusetts voters see it on TV.

Carl is the definition of a true progressive leader — he supports prosecuting Wall Street bankers, increasing Social Security benefits, passing Warren’s student loan bill, and reversing Citizens United.

His special election is right around the corner on October 15, voters are just starting to pay attention, and he needs our support.

Check out the ad, and donate $3 so Massachusetts voters will see it and elect a bold ally for Senator Warren.

Or, watch the ad and sign up to make calls from your home for Carl before Election Day!

Thanks for being a bold progressive.

— Stephanie Taylor, PCCC Co-founder