Stabilet Infant Warmer Recall-Draeger

August 25, 2009 by Jay Genkins  
Filed under Consumer Alerts

Stabilet Infant Warmer Draeger: Class 1 recall due to the reasonable probability that use of these products will cause serious injury or death.

The FDA issued a Class 1 recall models of the Stabilet infant warmer because they may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire.

On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]


Blair Robes Recall- 162,000 women’s robes recalled after 6 deaths

June 11, 2009 by Jay Genkins  
Filed under Defective Products, Recalls


Consumers are being urged to immediately stop wearing a certain type of chenille robe made by Blair LLC due to a fire hazard that is believed to have killed at least six people.

The Consumer Product Safety Commission and Blair LLC, based in Warren, Pa., on Thursday said they were issuing the second recall notice in two months after receiving reports of six deaths due to the robes catching on fire. In five of the six cases, the victims were women who were cooking at the time; three of the victims were in their 80s. The recall applied to 162,000 robes.

“CPSC urges all consumers to report any incidents or injuries involving consumer products, even after a recall has been announced,” said acting CPSC Chairman Thomas Moore. “Contact the CPSC so that we may help prevent tragic deaths or injuries like those that might be related to the Blair robes.”
CPSC and Blair initially announced their voluntary recall in April, citing three reports of the robes catching on fire, including one report of second-degree burns.

The robes, made in Pakistan, have the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They are a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

The robes were sold in Blair catalogs and on the company Web site, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009. Consumers may return the robe to Blair and receive a refund or a $50 gift card by contacting the company at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, via the firm’s Web site at Blair.com/recall, or by e-mail at blairproductrecall(at)blair.com.


Hydroxycut Recall Information – 5/2/2009

Products included in the Hydroxycut Recall

  • Hydroxycut Regular Rapid Release Caplets
  • Hydroxycut Caffeine-Free Rapid Release Caplets
  • Hydroxycut Liquid Shots
  • Hydroxycut Hardcore RTDs (Ready-to-Drink)
  • Hydroxycut Max Aqua Shed
  • Hydroxycut Hardcore Liquid Capsules
  • Hydroxycut Max Liquid Capsules
  • Hydroxycut Regular Drink Packets
  • Hydroxycut Caffeine-Free Drink Packets
  • Hydroxycut Hardcore Drink Packets (Ignition Stix)
  • Hydroxycut Max Drink Packets
  • Hydroxycut 24
  • Hydroxycut Carb Control
  • Hydroxycut Natural

Users of Hydroxycut should be aware of symptoms of possible liver damage from hydroxycut, including, jaundice, brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.


Hydroxycut liver failure, injury and death – FDA Warning

May 1, 2009 by Jay Genkins  
Filed under Consumer Alerts, FDA, Recalls

May 1 , 2009 – FDA Recall of Hydroxycut due to kidney and liver failure, cardiovascular disorders and even death

As millions of people in the United States attempt to lose weight for a plethora of reasons, many are turning to different products to help them do so. As a result, companies are beginning to research, develop and market these products as a way to accomplish the weight loss they desire in a fast and safe manner.

Unfortunately, some of these weight loss aids are proving to be dangerous, and that appears to be the case with one of the most popular product lines on the market – Hydroxycut products by Iovate Health Sciences, Inc. Below is a brief overview of the burgeoning issue with these products:

The Products

The products at issue are the line of Hydroxycut weight loss aids that are marketed to help consumers weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss, all of which are meant to promote better health because of less weight. These products sold in huge numbers since hitting the market, and they are seen as cost-effective and efficient.

The Problems

The problems that have arisen in response to using them have been not only numerous, but serious in nature.

Specifically, these problems include:

  • Seizures
  • Cardiovascular disorders
  • Rhabdomyolysis – A type of muscle damage that can lead to other serious health problems such as kidney failure.

Perhaps most serious is the trend that points towards different forms of liver damage. These different forms of damage include jaundice and elevated liver enzymes, which can lead to the immediate need for a liver transplant.

At this point, at least 23 reports of serious side effects developing as a result of using these products and one death has been reported. Given the small sample pool and the relatively short amount of time in which they have been generated, the US Food and Drug Administration (FDA) has decided to act now.

FDA’s Response

The FDA has recently issued a public warning to all consumers that they should immediately stop using any of these products until additional investigations can be completed regarding Hydroxycut weight loss products. This investigation centers on the ingredients present in the products and other factors included with their usage.

If you or someone you love has been harmed as a result of using Hydroxycut weight loss products, contact a defective drugs lawyer as soon as possible to schedule a free initial consultation.


Bone Screw Recall – Calaxo Screws

April 16, 2009 by Jay Genkins  
Filed under Consumer Alerts, Recalls

Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were
first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate
ligament (ACL) reconstruction.

Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the
appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is
currently investigating the cause of this problem.

Most cases resolved without intervention. A small number of cases needed local debridement and
removal of any remaining screw fragments, or replacement with an alternative screw or bone graft.
The manufacturer estimates that about 2,550 devices have been used in the UK since 2006.
The manufacturer is aware of seven reported cases of inflammation in the UK of which two
required implant revision.

The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who
were known to use CALAXO about this product recall in August 2007 (see MHRA website). This
notice is to facilitate the recall.


Digoxin Recall – Caraco Brand

April 1, 2009 by Jay Genkins  
Filed under Recalls

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.

Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability.

Consumers with the recalled product should return these products to their pharmacy or place of purchase.


Pistachios Recall Salmonella Warning

March 31, 2009 by Jay Genkins  
Filed under Consumer Alerts, Recalls

A California pistachio processor issued a nationwide voluntary recall on Tuesday of pistachios due to potential salmonella contamination.

The U.S. Food and Drug Administration and the California Dept. of Public Health are investigating the matter. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios, the FDA said.

The recalled nuts were shipped on or after Sept. 1, 2008 by Setton Pistachio of Terra Bella Inc.


Propafenone HCL Tablets Recall

March 25, 2009 by Jay Genkins  
Filed under Consumer Alerts, Recalls

propafenone_hcl_tablets_recall

Propafenone HCL Tablets 225 mg Recall

Recalled lot number: 112680A, expiration date July 31, 2010
Product Name: Propafenone HCL tablets
Shipped: Between October 15, 2008 and November 26, 2008.

The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc.

Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially , including arrhythmias (irregular heartbeat) or low blood pressure.

Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.

Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled. Anyone with 225 mg Propafenone HCL tablets being recalled should call (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.

Any adverse reactions experienced with the use of this product, and/or quality problems 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, or on the MedWatch Web site at www.fda.gov/medwatch


Baxter Infusion Pump Recall

March 12, 2009 by Jay Genkins  
Filed under Defective Products, Recalls

A Class 1 Recall of  Baxter infusion pumps by the FDA.

Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter
The Model numbers are:

  • Mono 2M8151 and 2M8153
  • CX 2M8161 and 2M8163
  • CXE 2M9161 and 2M9163

The defective Pumps were manufactured and distributed from February, 1997 through December, 2008.

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.


Complete List Peanut Butter Products Recalled to Date

February 11, 2009 by Jay Genkins  
Filed under Defective Products, FDA, Guides

peanut_butterPlease see below for the complete list of recalled peanut butter products as of Feb 10 2009.

For the current list and more information, the best place to go is the FDA page dedicated to this.
http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html

Peanut Butter Recall List – Feburary 2009 FDA Press Releases

Peanut Butter Recall List – January 2009 FDA Press Releases

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January 2009 Press Releases

—————-More information from the CDC———————-

Update for February 9, 2009 (next web update will be available Thursday, February 12)

Today’s Highlights

salmonella under microscope

Outbreak Investigation | Recommendations/Advice to Consumers | Clinical Features/Signs and Symptoms | CDC’s Role in Food Safety | Previous Updates

Why has Salmonella been in the news recently?

The Centers for Disease Control and Prevention (CDC) has been receiving reports, from many states, of illnesses caused by a type of Salmonella called Salmonella Typhimurium. Several deaths may also be associated with this outbreak. Tests indicate that the people who became sick may have eaten the same contaminated food, because they were infected with the same strain of Salmonella Typhimurium (i.e., the strain of Salmonella shared the same genetic “fingerprint”). Additional information on the numbers of illness and the states in which they occurred can be found at www.cdc.gov/salmonella/typhimurium/.

Is the salmonellosis outbreak definitely linked to peanut butter?

A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and CDC enabled FDA to confirm that the sources of the outbreak were peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia, processing plant. Peanut paste is a concentrated product consisting of ground, roasted peanuts that is distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream.


Lean Cuisine Chicken Recall – Nestle Recall

November 18, 2008 by Jay Genkins  
Filed under Defective Products

Thousands of Lean Cuisine Chicken Meals have been recalled by Nestle. The world’s biggest food company, has announced a recall of about 880 thousand pounds of Lean Cuisine Chicken Meals that may contain foreign materials, the U.S. Department of Agriculture said.

Nestle received one report of injury and identified the objects as small pieces of hard plastic, the USDA said in a statement today.


White Rabbit Candy Recall -Possible Health Risk – Melamine

September 29, 2008 by Jay Genkins  
Filed under Defective Products

September 26, 2008 -

No illnesses associated with this product have been reported to date however as a precaution QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine.

Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.

The White Rabbit Creamy Candy is sold in 8 or 16 oz packages. All other flavors of White Rabbit Candy, including Assorted (Chocolate, Coconut, and Coffee), Red Bean, Coffee, Corn, Lychee, Mango and Strawberry are sold in 7 oz. packages. All packaging has a logo of a white rabbit on the front with the words “White Rabbit”.

The recall was initiated after it was discovered that product was contaminated with Melamine.

Consumers who have purchased White Rabbit Candy are urged to return it to the place of purchase for a full refund or discard it in their trash.

Consumers with questions may contact the company at (650) 697-6633.


Serrano & Jalepeno Peppers Recall – Salmonella

July 21, 2008 by Jay Genkins  
Filed under Consumer Alerts, FDA, Recalls

July 19, 2008 -

Grande Produce, LTD. CO of Hidalgo, Texas (hereinafter referred to as Grande Produce) is recalling Jalepeno Peppers and Serrano Peppers distributed between May 17th and July 17th, 2008; and Avocados, all sizes, with lot #HUE08160090889 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.

The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY.

The avocados being recalled were shipped in boxes labeled “Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico,” all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label.

No illnesses associated with this recall have been reported to date.

The recall is a result of sampling by the Texas Department of State Health Services and The North Carolina Department of Health and Human Services, which revealed that these products contained the bacteria. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services, The North Carolina Department of Health and Human Services and the company continue their investigation as to the source of the problem.

Consumers who purchased Avocados, Jalapeno Peppers and Serrano Peppers should contact their supplier to determine if their products are involved in the recall. Consumers with questions may contact the company at (956) 843-8575.


Morphine Sulfate Recall- Voluntarily Recall by Ethex Corp

ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with “60″ on one side, and “E” on the reverse.

No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation previously initiated the recall notification to wholesalers and retailers who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems may 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, or on the MedWatch website at www.fda.gov/medwatch.


Digitek Recall by FDA

May 5, 2008 by Jay Genkins  
Filed under Defective Drugs, Features

Several Brands of Heart Medication Recalled

Heart problems and heart failure are two of the leading causes of death in the United States every year. As a result, pharmaceutical companies everywhere are placing a high priority on the research and development of medications that will provide relief and the ability to manage these conditions for patients.

Unfortunately, every new drug hits the market with at least some degree of risk, and that appears to have been the case with a drug that’s been known under several names, including Digitek, which was formulated by Actavis Totowa LLC, Bertek, distributed by Mylan Pharmaceuticals, Inc. and UDL, which is put out by UDL Laboratories, Inc. All of these drugs have been recalled, effective immediately, according to an announcement by the companies in conjunction with the FDA on its Web site.

The problem with these drugs is that many of the pills that were manufactured were released with twice the normal thickness in other pills, which means by result that these faulty pills can contain twice the amount of medication necessary to treat these heart conditions. When a patient inadvertently doubles the dose of this drug, he or she can suffer from digitalis toxicity, particularly in this situation when the patients have experienced renal failure. This condition can lead to vomiting, nausea, low blood pressure, dizziness and a dangerously low resting heart rate, known as bradycardia.

If you are taking any form of this medication, you need to contact your doctor immediately to find out how you should proceed. If you’ve been injured by any of these medications, contact a defective drugs attorney as soon as possible to schedule an initial consultation.