Thursday, June 30, 2011

Best Burn Centers in the US

With the news of the NAPA firepot recall, some folks have been asking about burn centers that seem to be head and shoulders above the rest. Here is a compilation:


Shriners Hospitals for Children have hospitals devoted to burns. They are in BostonCincinnati, and Sacramento CA.
The University of Washington Harborview Medical Center. Harborview has treated over 15,000 since 1974. They treat nearly all the burn victims in Washington. They are also one of the first to adopt the removal of dead tissue as early as possible to prevent infection. Harborview Medical Center is located at 325 Ninth Avenue, Seattle, WA. They have a 96% survival rate with burns over 75% of the body.
Nationwide Children's Hospital, in Columbus, Ohio, at 555 South 18th Street, Suite 6G, Columbus, Ohio 43205.
Tampa General Hospital Regional Burn Center is one of only four burn centers in Florida. It is a 13 bed unit with expansion.
In the South, here are specialized burn centers:

Alabama

Children's Hospital of Alabama Medical Center
1600 7th Avenue South
Birmingham, AL 35233

Joseph M. Still Burn Center at Doctors Hospital of Augusta
3651 Wheeler Road
Augusta , GA 30909
www.doctors-hospital.net
Emory University Burn Center
Grady Memorial Hospital
80 Butler Street
Atlanta, GA 30335

Florida:

Orlando Regional Medical Center -- Burn / Tissue Rehab Unit
1414 South Kuhl Ave
Orlando, FL 32806-2134 United States
            407 841-5176 begin_of_the_skype_highlighting            407 841-5176      end_of_the_skype_highlighting      
Tampa General Hospital -- Tampa Bay Regional Burn Center
PO Box 1289
Tampa, FL 33601 United States
            813 251-7617 begin_of_the_skype_highlighting            813 251-7617      end_of_the_skype_highlighting      
University of Florida -- Shands Burn Center
1600 SW Archer Road
Gainesvillw, FL 32610 United States
            352 395-0200 begin_of_the_skype_highlighting            352 395-0200      end_of_the_skype_highlighting      
University of Miami -- Jackson Memorial Burn Center
1800 NW 10th Ave
Miami, FL 33136 United States


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Drug News Quick Takes

Pill tabletImage by doug88888 via FlickrAs we near the 4th of July long weekend, some quick links to this week's pharma/supplement news:


 "Neurontin Killed Our Husbands, We Believe"Adverse reactions to Neurontin have been greatly underestimated and unreported, claims one person interviewed in the article. Link here


FDA warns about delay in Offspring with Valproate:   The US Food and Drug Administration (FDA) has issued a safety announcement to underline the increased risk for lower cognitive test scores among children born to mothers taking the antiseizure medication valproate sodium or the related products valproic acid and divalproex sodium during pregnancy, relative to other antiepileptic medications. Link


Chelaton capsule maker signs Consent Decree: The Food and Drug Administration announced Thursday that Howard Sousa of the Artery Health Institute has signed a consent decree promising not to market his Advanced Formula EDTA Oral Chelation capsules as a drug. Link


FDA Warning Letters for June 2011: Medical device companies, those that make pharma products, food manufacturers that failed labelling. Link
 

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Tuesday, June 28, 2011

Aidapak Services, LLC Initiates Nationwide Voluntary Recall on Repackaged Pharmaceuticals by Aidapak

From the FDA:

Vancouver, Washington, Aidapak Services, LLC is conducting a nationwide voluntary recall to Hospital Inpatient Pharmacies for the products listed on the company’s website. The firm voluntarily recalled these products after learning of the potential cross contamination of non-penicillin drug products repackaged in the same facility. There is potential likelihood that a serious anaphylactic reaction in patients, with known hypersensitivity to beta-lactam or penicillin products, could result from receiving these products. This poses potential serious risk to a patient’s health.
Please click on the link provided below to view a complete listing of products affected by this recall. All products affected by this recall are stamped with Aidapak's packaging stamp.

http://aidapak.com/Recall/FDA%20Recall%20List%2020110601.pdf

There have been no reports of injuries reported to date.

Qualitest Pharmaceuticals Issues Nationwide Retail Level Recall of Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets

From the FDA:

Qualitest Pharmaceuticals today issued a voluntary nationwide retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg. This recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B. Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.

Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (Acetaminophen is in both preparations.) Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction. Side effects due to caffeine are less likely, due to the small amounts in this formulation, however, those individuals with a sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution. No injuries have been reported to date.
The recall includes the following products:
  • Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the manufacturer’s bottle. Butalbital, Acetaminophen, and Caffeine Tablets are (approximately 11.0 mm in diameter), white round-shaped tablets, debossed (2544) on one side, and debossed (V) on the reverse side; Hydrocodone Bitartrate and Acetaminophen Tablets are (approximately 16.5 mm in length), white with green specs, round, capsule shaped, scored tablets, debossed (3594) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets.
Tablet descriptions:

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg are supplied as white with green specks, capsule-shaped, scored tablets, debossed “3594” on one side and debossed “V” on the reverse side.

Butalbital, Acetaminophen and Caffeine Tablets, USP
Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed “2355” on one side, and debossed “V” on the reverse side.

Monday, June 27, 2011

Endo Pharmaceuticals recalls Endocet

Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV. One bottle from each lot of Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg, Lot # 402415NV and # 402426NV, NDC 60951-712-70, 100 count bottles, was found to contain some Endocet® 10 mg/650 mg Tablets, which are identifiable by their larger size, and different shape and markings. Currently, no other bottles from the subject lots or any other lots have been found to erroneously contain Endocet® 10 mg/650 mg Tablets.


The recall includes these lots of this product:
Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV, Expiry 01/2014; and

Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325 mg 100 count bottles, NDC 60951-712-70,Lot # 402426NV, Expiry 01/2014.



FDA source here. 

Older Diabetics: Are Several Drugs Linked to Increased Heart Risk?

In advance of an upcoming meeting of the American Diabetes Association ,  there is research that may claim to show that older people with type 2 diabetes who take drugs known as sulfonylureas to lower their blood sugar levels may face a higher risk for heart problems than their counterparts who take metformin. Source.
According to information being released this week,  the study was comprised of more than 8,500 people who were at least sixty five years of age, and older, who were diagnosed with type 2 diabetes. From the source, 12.4 percent of those given a sulfonylurea drug experienced a heart attack or other cardiovascular event, compared with 10.4 percent of those who were started on a drug known as metformin.

Sulfonylurea  drugs are derivatives that are part of a class of antidiabetic drugs that are used in the 

management of diabetes mellitustype 2. They act by increasing insulin release from the beta cells in 

the pancreas.
Metformin was originally sold as Glucophage. It is an an oral antidiabetic drug in the biguanide class.Source
Read more here

Cancer Reported in Certain Experimental Diabetes Drug

News this week concerning patients taking taking an experimental diabetes pill,  who had more breast and bladder cancers than those on a standard drug.
In all the clinical programs, nine breast cancers and nine bladder cancers were seen among 5,478 patients taking the drug, dapagliflozin, compared with one breast and one bladder cancer among the 3,156 in control groups, Bristol-Myers and AstraZeneca have both said. Importantly, there was no imbalance in overall cancer risk, the companies said. Source here

Saturday, June 25, 2011

Mensing v. Pliva - SCOTUS Opinion Affirming Preemption as to Generic Drugs

Drew Britcher has written this synopsis of Mensing and its effect that is worth a read: 

The U.S. Supreme Court released its opinion in Pliva v. Mensing today.  In a 5-4 decision, the Supreme Court narrowed its previous holding in Wyeth v. Levine (2009) and exempted generic drug manufacturers from lawsuits arising from inadequate warning labels.  At first blush, it is a peculiar decision in light of the recent 2009 Wyeth holding, where the Court found brand-name drug manufacturers liable for any deficiency on the warning label regardless of the federal regulations.  However, upon serious reflection, the decision reflects a strict interpretation of the Supremacy Clause and the role of the Supreme Court in federal preemption cases.  Although frustrating to admit, it appears that Justice Thomas, the author of the majority opinion and a member of the Majority in Wyeth, is consistent in his legal theories concerning the Supremacy Clause and federal preemption.    

The question presented was "whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-claims".  The parties in Pliva disputed whether the generic manufacturers were permitted to change their warning labels after they have received approval from the FDA.  The Court held that federal law does pre-empt state law because the FDA advised them that "it interprets its regulations to require that the warning labels of a brand-name drug and its generic copy must always be the same--thus, generic manufacturers have an ongoing federal duty of 'sameness.'"  As such, the Court determined that the "FDA's views are controlling unless plainly erroneous or inconsistent with the regulation[s] or there is any other reason to doubt that they reflect the FDA's fair and considered judgment."  (citation and internal quotation marks omitted)  (emphasis added).  In respect of Mensing and Demahy's arguments concerning the "changes-being-effected" (CBE) processes and "Dear Doctors" letters, the Court deferred to the FDA's interpretation of its CBE and its generic labeling regulations as well as deferring to the FDA's interpretation that Dear Doctor letters qualify as "labeling."  The Court declined to resolve the FDA's proposed different avenue for changing generic drug labels:  "According to the FDA, the manufacturers could have proposed --indeed, were required to propose--stronger warning labels to the agency if they believed such warnings were needed.  If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturers to create a new label for both the brand-name and generic drug."

The majority held that generic manufacturers need not comply with the same regulations and duties under state tort law because there is a federal law -- that was designed to encourage and speed up the process of introducing generic drugs into the marketplace -- requires the manufacturers to maintain the same warning labels as the corresponding brand-name drug labels.  As such, the Court found federal preemption because it was impossible for generic drug manufacturers to comply with both state and federal requirements.  "If the [generic manufacturers] had independently changed their labels to satisfy their state-law duty, they would have violated federal law."  Rejecting Mensing and Demahy's argument that the generic drug manufacturers "cannot bear their burden of proving impossibility because they did not even try to start the process that might ultimately have allowed them to use a safer label," the Court clarifies that "[t]he question for 'impossibility' is whether the private party could independently do under federal law what state law requires of it."  According to the majority, acceptance of Mensing and Demahy's argument would cause most conflicts between federal and state law to be illusory. 

However, the dissent emphasizes that "impossibility preemption" is a demanding affirmative defense; the defendant must prove that "compliance with both federal and state laws is a physical possibility," or more plainly, an "inevitable collision."  The dissent provides that the generic drug manufacturers could have raised the issue of inadequate warning labels with the FDA and asked the FDA to initiate a label change.  Thus, if the FDA agreed that a label change was necessary, it could require the brand-name to change its label; thereby allowing the generic drug manufacturer to change its label to conform with the corresponding brand-name label.  The dissent would find that the generic drug manufacturer's failure to initiate the aforementioned proposal to the FDA means they cannot sustain their burden of proving the affirmative defense of impossibility preemption.  However, the defense questions whether the generic drug manufacturers had the duty to invoke this potential mechanism for initiating label changes. 

In respect of Wyeth v. Levine, the Pliva Court stated that, although "Wyeth is not to the contrary," the majority recognized that "from the perspective of Mensing and Demahy, finding preemption here [in Pliva] but not in Wyeth makes little sense."  Brand-name manufacturers are not held to the same requirements as generic manufacturers -- they are permitted to change their warning labels whereas generic drug manufactures must ensure that their warnings conform to that of the brand-name drug.  The Court recognized the dissonance between plaintiffs injured by brand-name drugs and those injured by generic drugs, stating that the federal drug regulations has dealt an unfortunate hand to Mensing, Demahy and others similarly situated.  Regardless, the Court maintained that it was not the role of the Court to "decide whether the statutory scheme established by Congress is unusual or even bizarre."  More plainly speaking, the Court passed the ball to Congress (and the FDA) to rectify the situation.  It will be the efforts of Congress that determine whether plaintiffs injured by brand-name or generic drugs are treated equally in a court of law.  Ultimately, the Court refused to distort the Supremacy Clause to achieve a particular outcome that would, in their words, "create similar preemption across a dissimilar statutory scheme."

The dissenting opinion, authored by Justice Sotomayor, focuses on the fact that whether "consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug."  It is an outcome that entire Court agrees makes very little sense.  However, one could argue whether it is the role of the Court to "correct" the outcome, or leave the issue for Congress to tackle.  This case raises two important questions to be addressed in the near future:  (1) Will Congress act to rectify this dissonance between consumers injured by inadequate warning labels on brand-name drugs and those injured by inadequate warning labels on generic drugs and (2) Is there truly no possible legal relief for those injured in the generic drug context?  Could plaintiffs sue the brand-name manufacturers for their failure to maintain adequate warning labels, in turn causing generic drugs to have corresponding inadequate warning labels?  Such questions are likely to arise in the future and the Court's response shall be interesting.

The inescapable travesty of this case is that the statutory scheme leaves open the idea that this result can be justified

Friday, June 24, 2011

GAO: FDA Fails to properly initiate recalls, puts USA citizens at risk

Another scathing report on the poor job the FDA does as to food products. This one is from the Office of Audit Services of the Office of the Inspector General.

From the report: The FDA's guidance for developing and implementing food recalls was not adequate to ensure the safety of the Nation's food supply because it was not enforceable. In addition, FDA did not always follow its own procedures for ensuring that the recall process operated efficiently and effectively. FDA has established regulations as nonbinding guidance that FDA and the recalling firm should consider in planning and implementing a recall.

The GAO reviewed 17 recalls out of 40 the FDA played a role in over a two  year period. FDA did not always (1) conduct firm inspections or obtain complete information on the contaminated products, (2) conduct timely or complete audit checks of consignees, (3) review recall strategies and promptly issue notification letters to firms conveying the review results and other essential instructions, or (4) witness the disposal of the products or obtain the required documentation showing that the products had been properly disposed of by the recalling entity.

I'm reading the report now and will post about it later. Find it here.

FDA Workload Increases; Considers Outsourcing

The FDA is now suggesting that it work with other countries to assemble "global coalitions of regulators dedicated to building and strengthening the product safety net around the world," in the words of a report issued this week.

From the report:

“Global production of FDA-regulated goods has exploded over the past ten years.  In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  "There has been a perfect storm - more products, more manufacturers, more countries and more access.  A dramatic change in strategy must be implemented."

The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

3.  The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

"FDA regulated imports have quadrupled since 2000,” Hamburg said. "The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face.  The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission."

From where I sit, having reviewed the report, it's clear that Congress needs to double the inspection budget, add trained staff, and increase penalties. Cutting the budget threatens the safety of the food we eat and the pills that consumers take. 
A health insurance company is entitled to names and information identifying those insureds who have filed a lawsuit against a pharmaceutical manufacturer, according to a Philadelphia, PA judge who has ruled on the request.

UnitedHealth Group will make subrogation claims against GlaxoSmithKline for insureds who took Paxil and Avandia drugs. The carrier may sue the company over claims of injuries its insureds experienced by taking those drugs.

More here

Thursday, June 23, 2011

June 24, 2011: Napa Home & Garden (Based in GA) Fire Gel Recall News


 The Material Safety Data Sheet was found no this product on the Napa site. The MSDS a form with data regarding the properties of a particular substance.

An important component of workplace safety, it is intended to provide workers and emergency personnel with procedures for handling or working with that substance in a safe manner, and includes information such as physical data as well as storage, disposal, protective equipment, and handling procedures. An MSDS for a substance or product is not usually intended for use by a consumer, focusing instead on the hazards of working with the product in an occupational setting




On the Napa website, this warning:

NOTICE: BUYER ASSUMES ALL RESPONSIBILITY FOR SAFETY AND USE THAT IS NOT IN ACCORDANCE WITH INSTRUCTIONS AND WARNINGS. 
READ CAREFULLY BEFORE USE 
USE EXTREME CAUTION! - DANGER FLAMMABLE/IRRITANTEthanol Fuel is a Class 3 flammable liquid and presents real danger when not used in direct compliance with all Instructions and safety warnings.
KEEP FIRELITE AND GEL FUEL OUT OF REACH OF CHILDREN AND PETS

First-Time Use Instructions

1. PLACEMENT OF FIRELITE: Place FireLite in a safe, level, stable, non-flammable area
2. FUEL: Use only NAPAfire gel fuel, Regular or Citronella. Citronella is for outdoor use ONLY.

3. POURING: Slowly pour gel fuel into clean burner cup that is COOL TO THE TOUCH. Fill cup 3/4" from the top. Don’t overfill or allow gel fuel to touch anything other than the inside of the cup. Clean any spills with water before lighting. Replace cap on bottle and place bottle 5 feet or more away from the FireLite before lighting. Store fuel bottles in cool dry space. Do not store in direct sunlight or allowed fuel gel to become heated.

4. LIGHTING: Use long match or extended lighter to light gel fuel. CAUTION: The flame starts out slowly. DO NOT ASSUME THE GEL FUEL DID NOT IGNITE.

5. BURNING: DO NOT MOVE OR TOUCH FIRELITE WHEN LIT OR HEAT IS PRESENT. UNIT WILL BE VERY HOT. It is recommended that the gel fuel in the burner cup be burned completely.

6. EXTINGUISHING: To extinguish the flame, only use the snuffer that came with the FireLite. DO NOT USE THE FIRELITE LID TO EXTINGUISH. DO NOT BLOW OUT FLAME. Snuff for 20 seconds or longer. DO NOT ASSUME FLAME IS OUT BECAUSE YOU CANNOT SEE IT. 

Relighting & Refilling

WARNING: DO NOT ATTEMPT TO ADD FUEL TO BURNER IF FLAME IS PRESENT OR BURNER CUP IS HOT, THIS MAY CAUSE A FLASH FIRE AND SEVERE BURNS. FLAME MAY BE NEARLY INVISIBLE: APPROACH FIRE WITH CAUTION.

1. WAIT FOR THE FIRELITE AND CUP TO COOL TO ROOM TEMPERATURE. MAKE SURE THAT THE FLAME IS OUT AND NO HEAT IS PRESENT! CAREFULLY REFILL THE CUP NO HIGHER THAN 3/4" FROM THE TOP. DON’T OVER FILL.
2. Leftover fuel should be disposed of. Dispose unused fuel content and empty bottles in accordance with local regulations for hazardous materials.
3. Light with long match or extended lighter. CAUTION: The flame starts out slowly. DO NOT ASSUME THE GEL FUEL DID NOT IGNITE.
WARNINGS!

• IN CASE OF EMERGENCY, DIAL 911. EXTINGUISH FIRE WITH APPROVED FIRE EXTINQUISHER

• Ethanol Fuel, when not used correctly and safely can cause serious burns, destruction of property, or even death
• NEVER LEAVE A BURNING OR HOT FIRELITE UNATTENDED
• KEEP AWAY FROM CHILDREN AND PETS, THIS IS NOT INTENDED FOR CHILDREN
• DO NOT BURN IN CONFINED SPACE, THE FLAME CONSUMES OXYGEN
• DO NOT OBSTRUCT OR INHIBIT FLAME
• ALLOW FIRELITE TO COOL BEFORE TOUCHING OR MOVING
• EXERCISE THE SAME PRECAUTIONS AS YOU WOULD AN OPEN FIRE
• DO NOT USE FOR COOKING PURPOSES
• DO NOT TRANSFER FUEL TO ANOTHER BOTTLE OR MIX WITH ANY OTHER SUBSTANCE
• DO NOT SHIP THE FUEL BOTTLES BY AIR OR TAKE ON BOARD AN AIRPLANE AS CHECKED BAGGAGE OR CARRY ON LUGGAGE
• USE FUEL GEL WITHIN ONE YEAR OF PURCHASE
• USE ONLY WITH STAINLESS STEEL CUP PROVIDED WITH FIRELITE. DO NOT USE OTHER CONTAINERS
• READ INSTRUCTIONS AND FUEL BOTTLE LABEL BEFORE USE
Cleaning & Care
1. Clean the exterior of the FireLite with damp cloth. Do not use harsh chemicals. Bring indoors before frost or freezing.
2. Clean the cup with soap and water. Fine gauge stainless steel may be used for further cleaning.


Here is the release from the CPSC:

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Pourable NAPAfire and FIREGEL Gel Fuel bottles and jugs

Units: About 460,000 bottles and jugs

Distributor: Napa Home & Garden, of Duluth, Ga.

Hazard: The pourable gel fuel can ignite unexpectedly and splatter onto people and objects nearby when it is poured into a firepot that is still burning. This hazard can occur if the consumer does not see the flame or is not aware that the firepot is still ignited. Fuel gel that splatters and ignites can pose fire and burn risks to consumers.

Incidents/Injuries: Napa is aware of 37 reports of incidents, including 23 burn injuries to consumers.

Description: The product is a clear, pourable gel fuel packaged in clear one-quart plastic bottles and one-gallon plastic jugs and sold in non-scented and citronella scents. The fuel is poured into a stainless steel cup in the center of firepots or other decorative lighting devices and ignited.

Sold at: Bed Bath & Beyond, Shopko, Restoration Hardware, specialty and gift shops, furniture stores, and home and garden stores nationwide, as well as through Amazon.com, home and garden catalogs, and home decorators and landscape architects between December 2009 and June 2011 for between $5 and $78.

Remedy: Consumers should immediately stop using the pourable gel fuel in firepots and return all bottles or jugs to the retailer where the consumer purchased the fuel for a full refund. A retrofit for the Napa brand firepots is being evaluated and may be available in the near future.

Call us if a loved one may have been hurt by this product. 404-451-7781 or   (404) 635-6785

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