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Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks

Monday, March 5th, 2012

February, 2012 – (GLOBE NEWSWIRE) — Regeneca, Inc. (Pink Sheets:RGNA) announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company, through in

dependent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

If you or anyone you know has been hurt by any Regeneca, inc product, call us at: 877 882 0095

For original article see: //www.fda.gov/Safety/Recalls/ucm293376.htm

3/1/2012 Chelation News: FDA issues warnings to marketers of unapproved ‘chelation’ products

Saturday, March 3rd, 2012

The U.S. Food and Drug Administration today warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. The

re are no FDA-approved OTC chelation products.

The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.

The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care.

In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.

“These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.”

The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. The only FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as lead poisoning and iron overload. Procedures involving these agents carry significant risks and should be performed only under medical supervision.

The FDA has noted an increase in “chelation therapy” products marketed on the Internet that claim to cleanse the body of toxic chemicals and heavy metals. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. The products come in various dosage forms, including transmucosal sprays, suppositories, capsules, liquid drops, and clay baths.

Some of the companies also sell unapproved screening tests that claim to detect the presence of heavy metals in urine to justify the need for chelation therapy.

“FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness.” said Dara A. Corrigan, associate commissioner for Regulatory Affairs.

Under the FFDCA, companies that market products that claim to prevent, diagnose, treat or cure diseases must file an application with the FDA and provide data that demonstrate their products’ safety and effectiveness.

The companies must take prompt action to correct the legal violations cited in the warnings letters or face possible legal action, including seizure and injunction. The FDA issued warning letters to the following companies:

If you or anyone you know has been hurt by any Chelation, call us at: 877 882 0095

FDA Issues Warning to NY Drugmaker

Saturday, March 3rd, 2012

From a Buffalo news source:

APP Pharmaceuticals has received a warning letter from the Food and Drug Administration.

The letter notified the Staley Road manufacturer that the FDA expects it to “undertake a comprehensive and global assessmen

t” of its operations, particularly its “aseptic processing capabilities.”

The FDA inspected the plant in July, citing several “significant violations,” including insects found in vials of finished product, products with missing labels, a failure to follow quality- control procedures and improper investigating of customer complaints.

The latest letter says APP failed to properly address or correct the violations in its July response to the inspection. A statement from APP’s board of management said that the company has “full confidence” in its products’ quality and that it expects to respond satisfactorily to the FDA’s concerns.

The warning letter also said APP is manufacturing certain prescription drugs without an approved application. APP said the five drugs in question were “grandfathered,” or on the market long enough not to require FDA approval prior to 2006.

If you or anyone you know has been hurt by any APP Pharmaceutical products call us at: 877 882 0095

Source: //www.buffalonews.com/business/article744342.ece

Wisconsin: 29 lawsuits filed 2/23/12 alleged Imprelis-caused Tree Damage

Monday, February 27th, 2012

Twenty-nine lawsuits were filed Thursday against DuPont in Waukesha County by property owners alleging that the chemical giant’s herbicide Imprelis has killed or is killing their trees.

The lawsuits contend that DuPont marketed the weed killer

as being environmentally friendly and safe to use and “that is simply not the truth.”

“In its relatively short time on the market, DuPont’s Imprelis has proven to be a frighteningly effective tree killer,” the suits say.

Coniferous trees are particularly susceptible to being damaged or killed by the herbicide, according to the lawsuits.

Among those who are suing DuPont de Nemours and Co. are Summit Police Chief James Race and Waukesha County Circuit Judge Ralph Ramirez.

DuPont is facing similar lawsuits across the country Imprelis, which was first used in the fall of 2010, over tree death and damage.

The U.S. Environmental Protection Agency in August ordered DuPont to stop the sale and use of the herbicide, which was distributed and sold primarily to lawn care professionals.

Race’s lawsuit states that a lawn care service applied Imprelis to his property in Ottawa beginning in June of last year and that the herbicide was applied five times according to directions supplied by DuPont.

In the fall, a certified arborist examined trees on Race’s property and noted that 25 Norway spruce trees were 75% to 100% brown, dying and twisted, the lawsuit states and that there were other signs of death on all trees on the property.

Trees on a neighboring property also were damaged or dying, the suit says, even though the herbicide was not used on the property. The neighbors, Steven and Janette Zwicke, also are suing DuPont.

“I have 29 trees that are either dead or dying,” Race said Thursday. “I have a group of trees that lost their needles over the winter. DuPont knows they killed a lot of trees. They are not taking responsibility for it.”

The Zwickes lost a couple dozen trees, Race said.

Ramirez’s lawsuit says a lawn service applied Imprelis on the property of his Town of Waukesha residence one time in June and that by October, all eight trees on his property were showing signs of death.

DuPont spokeswoman Kate Childress said Thursday that the company is evaluating its response to the legal complaints.

“DuPont is committed to proper stewardship of all of its products. We are engaged in a comprehensive claims resolution process that fairly addresses claimed damage due to Imprelis,” the statement says.

Attorney Jay Urban, who filed the lawsuits on behalf of the Waukesha County homeowners, said “hundreds and hundreds” of trees have been killed by the herbicide in the county.

“It’s kind of a sad situation,” said Urban, who filed one similar case last fall in Waukesha County. That case was consolidated with cases filed in Pennsylvania, he said.

Urban said he expected to file about 100 more lawsuits in the next two weeks.

Source: //www.jsonline.com/news/waukesha/29-lawsuits-filed-against-dupont-over-tree-damage-jm4afsh-140211533.html

Novartis to Add Warnings to Rasilez Blood-Pressure Drug (Europe)

Monday, February 27th, 2012

Novartis is changing the product information for Rasilez, sold in the U.S. as Tekturna, to say that the drug should not be used to treat patients with diabetes or kidney problems who are taking certain other medicines.

The drugmaker is also

complying with a recommendation of the European Medicines Agency that the label include a warning against combining products containing aliskiren, the active ingredient in Rasilez, with heart drugs known as ACE inhibitors or ARBs, the agency said today in an e-mailed statement. Novartis halted a trial of the drug in December after it was linked to increased risk of stroke and kidney problems.

//www.bloomberg.com/news/2012-02-17/novartis-to-add-warnings-to-rasilez-blood-pressure-drug-1-.html

Infant Tylenol Recalled

Monday, February 27th, 2012

74,000 bottles of infant Tylenol have been recalled by Johnson & Johnson’s McNeil Consumer Healthcare division.
A faulty part of the dosing system — an interior cap call

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ed a “flow restrictor” — can get pushed down into the bottle. This interferes with the syringe used to measure each dose. It could result in kids getting too much or too little acetaminophen, the painkiller/fever-reducer that is Tylenol’s active ingredient.
The recall affects seven lots of infants’ Tylenol Oral Suspension 1 oz. Grape, sold over the counter across the U.S. The recalled infant Tylenol:

  • Has the UPC code 300450122308
  • Has lot numbers BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, or BJL2U00

If you or anyone you know has been hurt by any Infant Tylenol, call us at 877 882 0095

Read more at the source: //www.webmd.com/parenting/baby/news/20120217/infant-tylenol-recalled

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FDA to look into safety of caffeine inhalers

Monday, February 20th, 2012

Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-si

ze canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.

AeroShot went on the market late last month in Massachusetts and New York, and it’s also available in France. Consumers put one end of the canister in their mouths and breathe in, releasing a fine powder that dissolves almost instantly.

Each grey-and-yellow plastic canister contains B vitamins, plus 100 milligrams of caffeine powder, about the equivalent of the caffeine in a large cup of coffee.

AeroShot inventor, Harvard biomedical engineering professor David Edwards, says the product is safe and doesn’t contain taurine and other common additives used to enhance the caffeine effect in energy drinks.

AeroShot didn’t require FDA review before hitting the U.S. market because it’s sold as a dietary supplement. But Sen. Charles Schumer, D-N.Y., said he met with FDA Commissioner Dr. Margaret Hamburg and she agreed to review the safety and legality of AeroShot.

“I am worried about how a product like this impacts kids and teens, who are particularly vulnerable to overusing a product that allows one to take hit after hit after hit, in rapid succession,” Schumer said.

Tom Hadfield, chief executive of Breathable Foods, which makes AeroShot in France, said in a statement that the company will cooperate fully with the FDA’s review to address the issues raised by Schumer and is confident it will conclude that AeroShot is a safe, effective product that complies with FDA regulations.

The company said that when used according to its label, AeroShot provides a safe amount of caffeine and B vitamins and does not contain common additives used to enhance the effect of caffeine in energy drinks.

It said each AeroShot is not recommended for those younger than 18 and is not marketed to children.

Meanwhile, an FDA official who was at the meeting confirmed the decision, telling The Associated Press that the review will include a study of the law to determine whether AeroShot qualifies as a dietary supplement. The product will also be tested to figure out whether it’s safe for consumption, the official said.

The official spoke on the condition of anonymity because that official was not authorized to discuss the matter.

For original article see: //www.chicagotribune.com/business/breaking/chi-fda-to-look-into-safety-of-caffeine-inhalers-20120220,0,1259570.story

If you or anyone you know has been hurt by the Caffeine Inhaler, call us at: 877 882 0095

FDA reiterates concerns with diet pill as drugmaker prepares to make second push for approval

Friday, February 17th, 2012

Federal health officials say they still have safety concerns about an experimental diet pill from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug’s safety next week.

Vivus, based in Moun

tain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA had rejected the diet pill Qnexa in October 2010. Vivus has resubmitted the drug with additional follow-up information, hoping for a more favorable ruling.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

For original article see: //www.washingtonpost.com/business/fda-reiterates-concerns-with-diet-pill-as-drugmaker-prepares-to-make-second-push-for-approval/2012/02/17/gIQAbUDfJR_story.html

Regeneca, Inc. Issues A Voluntary Nationwide Recall Of A Specific Lot Of RegenArouse Because Of Potential Health Risks

Thursday, February 16th, 2012

February 10, 2012 – Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs.

Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.

RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and had received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. The Company learned today that there was an error on this test and has thus made the decision to issue a voluntary nationwide recall on this lot of RegenArouse. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenArouse product matching the lot number above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

If you or anyone you know has been hurt by any Regeneca, Inc. product, call us at: 877 882 0095

For original article see: //www.fda.gov/Safety/Recalls/ucm291546.htm

FDA Shuts Down NJ Dental Company

Wednesday, February 15th, 2012

The Food and Drug Administration says a court order against Accurate Set requires the company to discontinue operations until the agency has verified its dental implants meet federal standards.

Accurate Set Inc., of Newark, N.J., and the com

pany’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.

Under the terms of the consent decree, Accurate Set must discontinue its operations until the U. S. Food and Drug Administration clears or approves its products, which include a variety of restorative dental products such as dental impression and repair materials. In addition, any future manufacturing must fully comply with the FDA’s quality standards.

“The FDA has very clear requirements for the clearance, approval, and production of medical devices,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

The FDA’s most recent inspection of Accurate Set, between December 2010 and January 2011, revealed significant violations of the FDA’s Quality System (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits. The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices.

Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.
Accurate Set and Adams have represented that they are no longer manufacturing or distributing any devices. If they decide to resume operations, they first must obtain FDA approval or clearance for their medical devices. The consent decree also requires them to comply with the QS regulation for all their devices and to retain an independent expert to inspect their operations and certify to the FDA that the necessary corrections have been made.

“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs.

In the event of future violations, the FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. The FDA can take other actions to ensure that they comply with FDA regulations, and may require Accurate Set and Adams to pay damages if they fail to satisfy the decree’s provisions.

//www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291648.htm

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