Recall: Vicks Sinex Spray

Posted by fitnfree in FDA Alerts on November 20th, 2009 |  No Comments »

P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom

The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries:  the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.  There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action.  The company’s analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product.  These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

The lot numbers of the products involved are:

 

Lot #

Country

Product Name

9239028831 United States Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray
9224028832 United Kingdom Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml
9224028833 Germany Wick Sinex Schnupfenspray Dosiersystem, 15 ml

 

This lot number is listed on both the outer carton and the bottle.  Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call:  1.877.876.7881 (Hours of operation:  Monday – Friday, 9AM – 6PM US ET, Saturday – Sunday, 9AM – 4PM US ET)

From the United Kingdom, please call:  0800.5555.15 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

From Germany, please call:  0800.111.6131 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

Any adverse events with the use of this product and/or quality problems should be reported via the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Source: FDA

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Recall: Nassau Candy

Posted by fitnfree in FDA Alerts on November 19th, 2009 |  No Comments »

Nassau Candy Issues Nationwide Allergy Alert Because Of Possible Undeclared Allergens on their Tasty Dish Snack Tubs of Chocolate Almonds, Chocolate Raisins and Sour Neon Worms

Nassau Candy Distributors of Hicksville, New York, is voluntarily recalling possibly unlabeled pegable snack tubs because they contain the following undeclared allergens; Tree Nuts {Almonds}, Soy and Milk and may contain the following undeclared allergens Peanuts, other Tree Nuts {brazil nuts, walnuts, filberts, hazelnuts, pecans, pistachios, macadamia nuts,  cashews and coconut}.  People who have an allergy to any of these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.

The Tasty Dish Snack Tubs weredistributed and sold nationwide to Bed Bath & Beyond retail stores.

The products come in clear plastic packages that have a triangular front label identifying the Brand: Tasty Dish, the Product Name: Chocolate Almonds, Chocolate Raisins, or Sour Neon Worms and the Net Weight: Chocolate Almonds are 9.75 oz. (276g), Chocolate Raisins are 11oz. (311), and Sour Neon Worms are 9.5 oz. (269g) and they all have a 4” clear film safety shrink band on them.  Sku numbers and UPC numbers listed below.

ITEM DESCRIPTION SKU UPC
TUB MLK ALMND 9.75Z

16915300

444444564610

TUB SOUR WORMS 9.5Z

16915289

444444564603

TUB MLK RAISN 11Z

16915335

444444564627

No illnesses have been reported to date in connection with this problem

This voluntary recall was initiated after receiving a report that a small percentage of the tubs in the retail locations were missing the back label.  All of the retails stores have been inspected and any tubs that are missing the back labels have been removed from the shelves.  Subsequent investigation indicates the problem was caused by a temporary breakdown in the packaging process. The labeling machine that applied the back label which contains the ingredient statement, nutritional information and allergen listing experienced a mechanical malfunction that went undetected by the operator.

Consumers who have purchased these Tasty Dish Snack Tubs and find no back label containing the ingredient statement, nutritional information and allergen listing are urged not to consume the product and to return it to Bed Bath & Beyond for a full refund. Consumers with questions may contact Nassau Candy directly at 516-433-7100 ext 297, Monday – Friday 9 am -4 pm ET.

Source: FDA

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Mummies Had Heart Disease

Posted by fitnfree in Free our Food!, To Your Health! on November 19th, 2009 |  No Comments »

Researchers examining Egyptian mummies discovered that our predecessors 3,500 years ago also suffered from hardened arteries, and they didn’t eat fast food. As The Wall Street Journal reports:

[Researchers] were able to identify the hearts, arteries or both in 16 of the mummies, nine of whom had deposits of calcification…
“Not only do we have atherosclerosis [artery hardening] now, it was prevalent as long as 3,500 years ago,” said Gregory Thomas, a cardiologist and imaging specialist at University of California, Irvine, who was principal investigator of the study. “It is part of the human condition.”

One of the researchers noted, heart disease “is as old as the pyramids.”

So why in the world are our tax dollars funding people to pick on every type of food available to us when it’s quite clear that it isn’t fast food, or meat or any type of modern convenience causing heart disease – it’s nothing more than being human.  So, consider telling your local lawmakers you want gov’t OUT of the food business.

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Recall: Snacks on Racks

Posted by fitnfree in FDA Alerts on November 18th, 2009 |  No Comments »

SNACKS ON RACKS, INC. Issues Nationwide Allergy Alert because of Undeclared Allergens in Their Gourmet Snacks Pack Product Line

Snacks on Racks, Inc. of Parkville, Missouri is recalling products from their line of Gourmet Snacks Packs because they may contain undeclared milk, peanuts, tree nuts, soy, egg, sulfites or wheat. People who have an allergy or severe sensitivity to milk, peanuts, tree nuts, egg, sulfites, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. The complete list of recalled products are listed at the end of this press release.

Gourmet Snack Packs are distributed throughout the continental United States to food service establishments at hospitals, colleges, universities and corporate cafeterias and kiosks. Gourmet Snack Packs are not sold to convenient stores, gas stations, grocery or mass market retailers.

Gourmet Snack Packs are packaged in clear, rectangular-shaped, safety sealed, plastic container with a blue Snacks on Racks label adhered to the top of the product. The retail packaging is not marked with any codes, UPC numbers, or expiration dates. A date code is stickered on the case packaging only. Consumers will be able to distinguish between the recalled product and the correctly-labeled new product because the new product will have the recycling symbol located in the bottom right corner of the label.

No illnesses have been reported to date in connection with this problem.

The recall was initiated when it was discovered that the Snacks on Racks labeling for chocolate raisins did not match the original manufacturer’s allergen statement. Subsequent investigation indicates the problem occurred in the company’s production and packaging processes. Snacks on Racks has implemented new processes to ensure customer safety.

Consumers who have purchased Snacks on Racks Gourmet Snack Packs are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-816-505-9131 between the hours of 8am to 4pm CST Monday through Friday or visit the website at www.snacksonracks.com.

Source: FDA

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Deep Belly Fat

Posted by fitnfree in Fit Facts on November 17th, 2009 |  No Comments »

Visceral fat is deep fat – inside your belly, where it grows around your vital organs. The more you have, the greater your chance of diabetes and heart disease.

But researchers say that people who lost weight and exercised to keep the weight off for a year kept the insides of their bellies skinny.

At the University of Alabama at Birmingham, Gary Hunter had some people train aerobically, and others do resistance with weights:

The people who aerobic and resistance trained and continued to do that gained back no visceral fat at all – zero.

Still others, who lost weight but didn’t exercise – or who stopped exercising – gained back about one third of their visceral fat

The study in the journal Obesity was supported by the National Institutes of Health.

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Caffeinated Alcoholic Beverages

Posted by fitnfree in Free our Food! on November 16th, 2009 |  No Comments »

More regulations, more businesses hurt, more items off the shelves…looks like gov’t is trying to take over the entire food industry, too. 

FDA to Examine the Safety of Caffeinated Alcoholic Beverages

On Nov. 13, 2009, the Food and Drug Administration (FDA) sent letters notifying nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” says Joshua Sharfstein, M.D., principal deputy commissioner of food and drugs.

As many as 26 percent of U.S. college students use the combination of caffeine and alcohol, according to the few studies on this topic.

Under the Federal Food, Drug and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless:

  1. its particular use has been approved by FDA regulation
  2. the substance is subject to a prior sanction, or
  3. the substance is “generally recognized as safe” (GRAS)
  4. For a substance to be generally recognized as safe, there must be evidence of its safety at the levels used, and a basis to conclude that this evidence is generally known and accepted by qualified experts

To date, FDA has approved caffeine only as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. The agency has not approved caffeine for use at any level in alcoholic beverages; therefore, these beverages can be lawfully marketed only if their use is subject to a prior sanction or if their use is GRAS.

FDA alerted manufacturers that it is considering whether caffeine can lawfully be added to alcoholic beverages. The agency noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.

FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA’s letter informed each company that if FDA determines that the use of caffeine in the firm’s alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, major brewers Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages (Tilt and Bud Extra, and Sparks) and agreed to not produce any caffeinated alcohol beverages in the future.

The U.S. Treasury Department’s Tax and Trade Bureau, which has primary responsibility for regulating alcoholic beverages, requires that alcoholic beverages contain only ingredients that satisfy FDA’s requirements for use.

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Recall: Blue Bonnet Light Spread

Posted by fitnfree in FDA Alerts on November 13th, 2009 |  No Comments »

Conagra Foods Issues Nationwide Allergy Alert on a Limited Number of 15 oz. Tubs of Blue Bonnet Light Spread

Today, ConAgra Foods, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of 15 oz. tubs of Blue Bonnet Spread that were inadvertently mispackaged—the lid is for regular Blue Bonnet Spread and the tub portion describes the product as Blue Bonnet Light Spread. The product inside of the tub is regular Blue Bonnet Spread. As a result, the product tubs do not declare the allergen whey (milk), as an ingredient.

People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. No allergic reactions have been reported.

This issue affects only 1,120 cases of a single lot code of the product. The product UPC on the tub is 27000-00930. The product lid will not have the blue ribbon graphic bearing the word “Light” that is found on the tub portion of the package. The rim of the lid will feature the batch code “2247923200″ and a Sell By date of March 18, 2010.

ConAgra Foods became aware of the issue after receiving a report from a store where the tub did not match the lid or the case.

The company is issuing a news release and an alert through the Food Allergy & Anaphylaxis Network (FAAN) (www.foodallergy.org), in an effort to notify any potentially affected consumers.

ConAgra Foods will work with retail customers to ensure that the recalled products are removed from store shelves. In the event that consumers believe they have purchased products affected by this voluntary recall, they should return the product to the store where it was purchased for a full refund. Consumers with questions may call 866-518-4177 (9:00 a.m. to 7:00 p.m. CST daily) or visit www.bluebonnet.com for more information.

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Recall: Weight Loss Supplement

Posted by fitnfree in FDA Alerts on November 13th, 2009 |  No Comments »

GMP Herbal Products, Inc. Issues a Voluntary Nationwide Recall of a Weight Loss Supplement Found to Contain Undeclared Drug Ingredients

 

Company Contact: 
Mike Le 
866-995-8585

FOR IMMEDIATE RELEASE – November 12, 2009 – Westminster, CA – GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients.  FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as drug; therefore the safety and effectiveness of this product is unknown.  All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.

The products listed above were sold and distributed nationwide via the internet.

FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

No illnesses or injuries have been reported to the company to date in connection with this product.

GMP Herbal Products, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. GMP Herbal Products, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers are advised to destroy the above products or return them to the company’s address in Westminster, CA. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585.  

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Source: FDA

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Ground Beef Q & A

Posted by fitnfree in Food Facts on November 11th, 2009 |  No Comments »

Outbreaks of E. coli in America sicken people and are often linked to deaths, health officials say. Scary thing to think simply eating a burger could be so serious. A little knowledge and consistent practice of sensible safety measures can avoid this calamity.

Also note that you should always, ALWAYS avoid imported meats for safety reasons.

As a result of these concerns, questions about “ground meat” or “hamburger” are in the top five food topics of calls to the USDA’s Meat and Poultry Hotline. 

Follow this link for the most frequently asked questions.

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Weekly eZine!

Posted by fitnfree in To Your Health! on November 10th, 2009 |  No Comments »

This week’s edition is on its way. Included is:

  1. Featured Article: Budget Friendly Beans
  2. Fitness Tip:  Step Lively
  3. Nutrition Tip:  Vitamin C for Gout in Men
  4. Supplement Special:  Extra Virgin Coconut Oil
  5. Quote of the Week
  6. Quick Recipe:  Overnight Oatmeal
  7. Featured Product of the Month:  Phen375 for Rapid Weightloss
  8. Tidbit:  Give someone you love a toothbrush
  9. Food Facts
  10. Freebies and Promos

View it online if you’d like, or sign up to receive it in your inbox weekly so you never forget!

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