Source | FDA

November 12, 2007 — Del Rey Tortilleria, Inc., Chicago, Illinois, is announcing the recall of its flour tortilla products.

Included in the recall are flour tortillas of all sizes [White Flour Tortillas; Tortillas de Harina(6 inch); Burritos 2, 3, and 4; and Fajita 8″ size] with the name “Del Rey” on the label, and with one of these Date Codes: OCT/17/07; OCT/20/07; OCT/24/07; NOV/04/07; NOV/10/07; or NOV/11/07.

Illinois state officials have told us that they believe there is a connection between the tortillas and recent illnesses in Racine, WI schools, in which students experienced vomiting, nausea and abdominal cramps. If you experience symptoms of this type, you should consult a health professional.

State officials have told us that they do not believe the problem involves microbial contamination. Del Rey is not certain that its products caused the reported symptoms, but is recalling the product nevertheless as a precaution while its investigation continues.

This recall does not affect any other Del Rey products.

The products were distributed nationwide through food distributors and grocery stores.

Consumers should immediately return any product that is subject to this recall to the store where it was purchased for a full refund or replacement.

Do I Have a Food Poisoning Lawsuit?

The Personal Injury Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in food poisoning lawsuits. We are handling individual and group outbreak litigation nationwide and currently accepting new food poisoning cases in all 50 states.

If you or a loved one have been the victim of food poisoning, you should contact us immediately. You may be entitled to compensation for your food poisoning related injuries.

Learn More: Food Poisoning

Source | Cargill Meat Solutions 

Action due to possible E. coli O157:H7 contamination

November 3, 2007 –Cargill Meat Solutions said it is voluntarily recalling approximately 1,084,384 pounds of ground beef produced at its Wyalusing, Pa., Cargill Regional Beef facility because of the possible presence of E. coli O157:H7. The ground beef products subject to recall were produced at the Wyalusing plant between Oct. 8 and 11, 2007, and were distributed to retailers nationwide.

Cargill learned of the possibility of contamination after the U.S. Department of Agriculture returned a confirmed positive on a sample of product produced Oct. 8, 2007.

“No illnesses have been associated with this product,” said John Keating, president, Cargill Regional Beef. “We are working closely with the USDA to remove the product from the marketplace.”

Products subject to recall are:

Each package or label bears the establishment number “Est. 9400” inside the USDA mark of inspection. As the use/freeze-by dates for products subject to this recall have expired, consumers are urged to look in their freezers for these products and return or discard them if found.

States impacted by the recall are: Connecticut, Maine, Maryland, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania and Virginia.

In addition to the above listed products, there are various weights and varieties of ground beef, ground chuck, and ground sirloin product that were distributed for further processing and repackaging and will not bear the same establishment number on the package.

Consumers with questions about the recall should contact the company’s food safety line at 1-877-455-1034. Media with questions should contact the company’s media representative, Lori Fligge, at 952-742-2275.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. The very young, seniors and persons with compromised immune systems are the most susceptible to foodborne illness. Food safety experts recommend cooking any ground beef to an internal temperature of 160 degrees F., or until the meat is no longer pink and the juices run clear. Also, avoid contaminating other foods with any E. coli bacteria that may be present in meat by:

Consumers with food safety questions also can “Ask Karen,” the FSIS virtual representative available 24 hours a day at ASKKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Consumers with food safety questions also can “Ask Karen,” the FSIS virtual representative available 24 hours a day at ASKKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Note from Attorneys

If you feel that you, your child or someone you know has been sickened by one of the frozen hamburger patties included within this recall, you should seek professional medical attention immediately by visiting your doctor of by dialing 911.

FREE Case Evaluation: If you or a loved one have been the victim of food poisoning, you should also contact us immediately. You may be entitled to compensation for your food poisoning related injuries.

The recall list below includes ONLY products included in the November 3, 2007 meat recall. The Cargill Meat Solutions ground beef products subject to the most recent recall are as follows:

Each package or label bears the establishment number “Est. 9400” inside the USDA mark of inspection. As the use/freeze-by dates for products subject to this recall have expired, consumers are urged to look in their freezers for these products and return or discard them if found.

Learn More: Cargill Meat Solutions Recall

Source | Cargill Meat Solutions

Action due to possible E. coli O157:H7 contamination

October 6, 2007 –Cargill Meat Solutions said it is voluntarily recalling approximately 844,812 pounds of frozen ground beef patties because they may be contaminated with E. coli O157:H7.

The recall is based on an investigation by the Minnesota Department of Health and Minnesota Department of Agriculture, as well as Cargill’s investigation and findings from a food safety assessment conducted by the U.S. Department of Agriculture at the Cargill Meat Solutions ground beef plant in Butler, Wis. Minnesota officials had investigated four cases of E. coli O157:H7 infection involving individuals who had consumed American Chef’s Selection Angus Beef Patties purchased at Sam’s Club stores in the state. While the investigation is ongoing, Cargill is voluntarily recalling the products based on a preliminary analysis of epidemiological data.

The products subject to the recall were produced on Aug. 9, 10, 15, 16 and 17, 2007, and were distributed nationwide. Each package bears the establishment number “Est. 924A” inside the USDA mark of inspection. The products include:

Products distributed at the retail and subject to recall are:

Products distributed to restaurants and institutions and subject to recall include:

“We are concerned that some consumers may still have the product sold at retail in their freezers,” said Bill Rupp, president of Cargill Meat Solutions. “We and Sam’s Club are urging customers to return or destroy any American Chef’s Selection Angus Beef Patties purchased in any of their stores since August.”

Rupp said the company learned of the situation shortly before noon on Friday. Based on information from Minnesota and USDA officials, the company investigated further and expanded the scope beyond Minnesota. Although the extent of any contamination is unknown, Cargill Meat Solutions has undertaken the voluntary recall as a proactive and cautionary step.

Consumers with questions about the recall should contact the company’s food safety line at 866-567-7899. Media with questions should contact the company’s media representative, Mark Klein, at 952-742-6211.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. The very young, seniors and persons with compromised immune systems are the most susceptible to foodborne illness. Food safety experts recommend cooking any ground beef to an internal temperature of 160 degrees F., or until the meat is no longer pink and the juices run clear. Also, avoid contaminating other foods with any E. coli bacteria that may be present in meat by:

Consumers with food safety questions also can “Ask Karen,” the FSIS virtual representative available 24 hours a day at ASKKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Note from Attorneys

If you feel that you, your child or someone you know has been sickened by one of the frozen hamburger patties included within this recall, you should seek professional medical attention immediately by visiting your doctor of by dialing 911.

FREE Case Evaluation: If you or a loved one have been the victim of food poisoning, you should also contact us immediately. You may be entitled to compensation for your food poisoning related injuries.

The following products are subject to the October 6, 2007 recall and were produced on Aug. 9, 10, 15, 16 and 17, 2007, and were distributed nationwide. Each package bears the establishment number “Est. 924A” inside the USDA mark of inspection. The products include:

Products distributed at the retail and subject to recall are:

Products distributed to restaurants and institutions and subject to recall include:

Learn More: Cargil Meat Solutions Recall

Source | FDA

The U.S. Food and Drug Administration (FDA) today announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study’s researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study’s termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Do I have an Trasylol Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Trasylol lawsuits. We are handling individual litigation nationwide and currently accepting new Trasylol cases in all 50 states.

If you or a loved one have recently undergone heart surgery and subsequently suffered from a heart attack, stroke or developed kidney or renal failure, you should contact us immediately. You may be entitled to compensation for your injuries by filing a Trasylol lawsuit and we can help.

Learn More: Trasylol Recall

Source | FDA

Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery.

Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The data also suggested that fewer patients receiving the drug experienced serious bleeding events.

This most recent data support the results from other comparison studies of Trasylol. The comparison studies were discussed at a September 2007 joint meeting of FDA’s Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees, which represent one part of FDA’s oversight and review of drugs throughout their life cycles.

FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. FDA will work with the sponsor of the recently terminated study to evaluate the data fully.

In the meantime, FDA recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.

In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Trasylol is marketed by Bayer Pharmaceuticals Corp., Leverkusen, Germany.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews. Full text of the Early Communication about an Ongoing Safety Review can be found at http://www.fda.gov/cder/drug/early_comm/aprotinin.htm.

Do I have an Trasylol Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Trasylol lawsuits. We are handling individual litigation nationwide and currently accepting new Trasylol cases in all 50 states.

If you or a loved one have recently undergone heart surgery and subsequently suffered from a heart attack, stroke or developed kidney or renal failure, you should contact us immediately. You may be entitled to compensation for your injuries by filing a Trasylol lawsuit and we can help.

Learn More: Trasylol Recall

Source | Wikipedia

Increasingly higher dosages will result in higher toxicity, resembling vitamin A toxicity. Adverse drug reactions associated with isotretinoin therapy include:[4]

Common: mild acne flare, dryness of skin, lips and mucous membranes, infection of the cuticles, cheilitis, itch, skin fragility, skin peeling, rash, flushing, photosensitivity, nose bleeds, dry eyes, eye irritation, conjunctivitis, reduced tolerance to contact lenses, hyperlipidaemia, raised liver enzymes, headaches, hair thinning, myalgia and/or arthralgia.
Infrequent: severe acne flare, raised blood glucose level, increased erythrocyte sedimentation rate, fatigue.
Rare: impaired night vision, cataracts, optic neuritis, menstrual disturbances, inflammatory bowel disease, pancreatitis, hepatitis, corneal opacities, papilloedema, idiopathic intracranial hypertension, skeletal hyperostosis, extraosseous calcification, and it is believed that severe depression can occur, although there is no conclusive evidence for this.
The following adverse effects have been reported to persist, even after discontinuing therapy: alopecia (hair loss), arthralgias, decreased night vision, degenerative disc disease, keloids, bone disease. High dosages of isotretinoin have been reported to cause rosacea (a disease of severe facial skin redness and irritation).

Erectile dysfunction in the form of difficulty in maintaining erection was reported in several patients in a clinical study. The impotence may have been caused by the psychiatric side effects of isotretinoin.[11]

While vitamin E supplements have been advocated by some to reduce the toxicity of high-dose retinoids without reducing drug efficacy, test results have proven this to be false.[12]

Patients receiving isotretinoin therapy are not permitted to donate blood during and for at least one month after discontinuation of isotretinoin therapy due to reported birth defects to unborn children.

Teratogenicity (Birth Defects)

Isotretinoin is a teratogen and is highly likely to cause birth defects if taken during pregnancy. Isotretinoin is classified as FDA Pregnancy Category X and ADEC Category X, and use is contraindicated in pregnancy.[5]

The manufacturer recommends that pregnancy be excluded in female patients two weeks prior to commencement of isotretinoin, and that they should use effective contraception (sometimes two simultaneous forms are recommended) at least one month prior to commencement, during, and for at least one month following isotretinoin therapy.[13]

In the U.S. more than 2,000 women have become pregnant while taking the drug between 1982 and 2003, with most pregnancies ending in abortion or miscarriage. About 160 babies with birth defects were born. Consequently, the iPLEDGE program was introduced by the U.S. Food and Drug Administration on 12 August 2005 in an attempt to ensure that female patients receiving isotretinoin do not become pregnant – as of 1 March 2006, only prescribers registered and activated in iPLEDGE are able to prescribe isotretinoin, and only patients registered and qualified in iPLEDGE will be able to have isotretinoin dispensed.

Depression

Several studies have suggested a possible link between isotretinoin and clinical depression.[14][15] However, no conclusive evidence has been produced. Despite this, the argument that isotretinoin caused depression and suicide has won a few lawsuits, and is partially responsible for the strict control of the drug, especially in the United States. Various case reports of depression, suicidal ideation, suicide attempt, and suicide in patients treated with isotretinoin have been reported to the U.S. FDA Adverse Events Reporting System, with 431 cases reported between 1982 and May 2001 – of these 37 patients had committed suicide.[16] While analyses have suggested an association between isotretinoin therapy and depression, no causal relationship has been established and further studies are required.[17][18]

Studies have shown that patients with acne, the population group eligible to receive isotretinoin therapy, have an increased risk of clinical depression compared with the general population.[19][20] Chee Hong describes Isotretinoin-related depression as “an idiosyncratic side-effect”, claiming, often anxiety can bring on acne and depression, creating more anxiety.[21] Correspondingly, treatment of severe acne with isotretinoin has been shown to reduce anxiety and depression, for tests have shown acne to be a main depressant in most tested patients’ lives.[22][23]

One study utilising positron emission tomography (PET) showed functional brain imaging changes in patients treated with isotretinoin, however the clinical relevance of this finding is unclear.[24]

U.S. Representative Bart Stupak (D-MI) is known for his distrust of Accutane. He believes unadvertised psychological side effects from the drug drove his teenage son, Bartholomew Thomas “B.J” Stupak Jr., to commit suicide in 2000.

Do I have an Accutane Lawsuit?

If you or a loved one have taken Accutane and experienced any side effects, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.

Learn More >>> Accutane Side Effects

Source | Wikipedia

Isotretinoin, when administered orally, is best absorbed when taken after a high fat meal, as it has a high level of lipophilicity. In a crossover study, it was found that the peak plasma concentration more than doubled when taken after a high fat meal versus a fasted condition. Isotretinoin is primarily (99.9%) bound to plasma proteins, mostly albumin. At least three metabolites have been detected in human plasma after oral administration of isotretinoin. These are 4-oxo-isotretinoin, retinoic acid and 4-oxo-retinoic acid. Isotretinoin also oxidises, irreversibly, to 4-oxo-isotretinoin. The metabolites of isotretinoin are excreted through both urine and feces. The mean elimination half-life is 21 hours, with a standard deviation from this mean of 8.2 hours.

Source | Wikipedia

Isotretinoin noticeably reduces the production of sebum and shrinks the sebaceous glands. It stabilizes keratinization and prevents comedones from forming. The exact mechanism of action is unknown, however it is known that like other retinoids, Isotretinoin works by altering DNA transcription.[3] This effect decreases the size and output of sebaceous glands, makes the cells that are sloughed off into the sebaceous glands less sticky, and therefore less able to form comedones.