Alert

Mountain Man Nut & Fruit Co.® Announces Voluntary Recall of Hazelnut

Company Contact:
Mike Conner,
303-841-4041 ext. 306

FOR IMMEDIATE RELEASE - December 18, 2009 - Parker, Colorado – Mountain Man Nut & Fruit Co. is voluntarily recalling select products containing shelled hazelnuts (filberts).

Mountain Man is initiating this recall in conjunction with the recall from Kunze Fams due to the fact that raw hazelnuts could have been exposed to salmonella and become contaminated. During routine inspection of the hazelnut shelling facility one salmonella test came back positive. In the interest of the safety of our customers, Mountain Man is requesting that customers return any of the lot codes below to their place of purchase for replacement or refund.

Mountain Man has not received any complaints of consumer illness associated with these products. This is strictly a precautionary recall to insure the safety of our customers.

All of the below is product that would have been manufactured and packaged since November 1, 2009 and December 17, 2009. Product purchased before or after these dates should not be affected by this recall.

Product Name	Lot Codes Affected
Filberts	289091A, 299091A
Natural Mixed Nuts	32009, 33809
Fancy Mixed Nuts – 8 & 16 oz bags	30909, 31309, 31709, 32009 32309, 32909, 33509, 33709 34209, 34309, 34809, 34909 35009
Choice Mixed Nuts – 16 oz bags	31309, 32709, 33609, 34909
Dry Roast Mixed Nuts – 16 oz bags	30909
Sweet Simplicity™ Trail Mix	32909
Mountain Jubilee® Trail Mix – 8 & 16 oz bags	31309, 32409, 33709, 34909
Cinnamon Almond Appleanche™ Trail Mix	31009
Fancy Mixed Nut Gift Packs – 1.75 lb	All product except 35009
Fancy Mixed Nut Gift Packs – 1 lb	All product except 35009

Product with these lot codes could also be present as a component in some of our gift baskets, including the 12 Tastes Basket, Bounty Basket and Half-Pound Sampler Basket. Because all of the products in a gift basket are individually packaged, only the above named products would be subject to this recall. Customers who receive these baskets can bring any of the above products to a distributor or store to receive a replacement product.

The above affected product has only been distributed through Mountain Man Distributors, Retail Stores and directly through our website.

Also note that any product sold in the State of Oregon is not affected by this recall.

Consumers who have purchased the recalled products should return them to their place of purchase for replacement product or a refund. Questions may be directed to the company at 1-800-225-0045, Monday-Friday between the hours of 7:00 AM and 4:30 PM MST.

About Salmonella

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other 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. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s Website at http://www.cdc.gov.

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Treatment

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Accelerated approval process used in vaccine approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

“As people grow older, their immune systems typically become weaker,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza.”

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

For more information

FDA Web Page on Vaccines, Blood & Biologics
http://www.fda.gov/BiologicsBloodVaccines/default.htm.

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Treatment

HHS HealthBeat

(December 24, 2009)

When do you need more help?

Listen to Tip Interested? Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

Most of the time, the best thing to do for the flu is treat symptoms and wait it out. Other times, that’s not enough, and you may need to seek more help.

But hospitals want to focus on people with greatest need. So how can you tell when to seek medical help?

At the Centers for Disease Control and Prevention, Dr. Joe Bresee:

[Dr. Joe Bresee speaks] "People with the following symptoms should call for emergency medical help immediately:

• Signs of breathing or heart problems, like chest pain, shortness of breath, bluish or purplish lips
• Signs of dehydration, like yellowish or leathery skin, decreased urination, or confusion. Sometimes, children will have no tears when they cry."

Common symptoms of seasonal and H1N1 flu include fever, cough, sore throat, runny or stuffy nose, body aches, headaches, chills, and tiredness.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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Health and

HHS HealthBeat

(December 22, 2009)

Yoga backs

Listen to Tip Interested? Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

A study indicates a form of yoga that stresses body alignment can help some people with lower back pain.

Kimberly Williams of West Virginia University examined that in people who did two 90-minute classes a week, and who were encouraged to do 30 minutes a day on other days, for 24 weeks. Williams says they reported 29 percent less disability, 42 percent less pain and 45 percent less depression than people who did not do yoga.

Her recommendation:

[Kimberly Williams speaks] "Get involved in active recovery, find a highly qualified certified teacher of yoga who has experience helping people with chronic low back pain, and I’d also encourage them to get their doctors involved."

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

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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Science

HHS HealthBeat

(December 23, 2009)

Kids without rotavirus

Listen to Tip Interested? Take the Next Step

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

At one time, rotavirus was something just about every kid had by the age of 5 years. It’s still that way in much of the world. But since 2006, there are vaccines, so we can prevent rotavirus’ diarrhea and dehydration. And researchers say the vaccines are making a difference in America.

At the Centers for Disease Control and Prevention, Dr. Jennifer Cortes:

[Dr. Jennifer Cortes speaks] "We’ve seen some pretty impressive declines in rotavirus disease. Some data shows up to 60 percent decreases in the number of rotavirus cases."

That’s important, because rotavirus can, in the worst cases, lead to hospitalization and possibly death.

Babies under 6 months can get the vaccines – there are two types, and both are liquids.

The study is in the Morbidity and Mortality Weekly Report.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Ira Dreyfuss.

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Treatment

Too Little Vitamin D May Worsen Asthma

Low levels may also hinder response to steroid treatment, study finds.

By Steven Reinberg
HealthDay Reporter

THURSDAY, Jan. 28 (HealthDay News) -- People with asthma who have low levels of vitamin D fare worse than those with high levels of the "sunshine" vitamin, a new study finds.

Researchers found that asthmatics with high vitamin D levels have better lung function and respond better to treatment than asthmatics with low vitamin D levels do.

"Our findings suggest that low vitamin D levels are associated with worse asthma," said lead researcher Dr. E. Rand Sutherland, from the division of pulmonary and critical care medicine at National Jewish Health in Denver.

In addition, vitamin D levels predict how well "somebody is going to respond to steroidal asthma medications," he said. "It may be that vitamin D is acting as a modifier of the immune system or a modifier of steroid response in ways that are relevant to people with asthma."

The report is published in the Jan. 28 online edition of the American Journal of Respiratory and Critical Care Medicine.

For the study, Sutherland's team took the vitamin D levels of 54 asthmatics and assessed lung function, airway hyper-responsiveness, which is the prevalence of airway constriction, and response to steroid treatment.

People with low levels of vitamin D in their blood did worse on the tests that evaluated lung function and airway hyper-responsiveness, the researchers found.

In those with vitamin levels below 30 nanograms per milliliter (ng/ml), airway hyper-responsiveness almost doubled, compared to those with more D in their blood.

Low vitamin D levels were also associated with a worse response to steroid therapy and increased production of the pro-inflammatory cytokine, TNF-alpha. This raises the possibility that low vitamin D levels are tied to increased inflammation of the airways.

The heaviest participants had the lowest levels of vitamin D, the study noted. Asthma is associated with obesity, and this (lack of vitamin D) may be a factor linking the two conditions, Sutherland said.

"There is a potential that restoring normal vitamin D levels in people with asthma may help improve their asthma," Sutherland said.

But whether vitamin D supplements will help asthmatics isn't known, he added.

Current recommendations for vitamin D supplements for adults is 400 IU to 600 IU, depending on age, according to the U.S. National Institutes of Health.

"There is likely little harm in adhering to those guidelines," Sutherland said.

The Institute of Medicine is currently evaluating these levels and expects to announce new guidelines in May.

Sunlight, fatty fish and fish oils are also sources of vitamin D.

Dr. Michael F. Holick, director of the Vitamin D, Skin and Bone Research Laboratory at Boston University School of Medicine, called this "a very nice study that confirms previous observations that vitamin D enhances lung function."

"It is also known that glucocorticoids [steroids] increase the destruction of vitamin D, thus making patients with asthma at higher risk for vitamin D deficiency, which in turn decreases lung function and makes their disease worse," he said.

Holick thinks most people, asthmatic or not, get too little D and should take supplements.

"It's pretty clear that you need a minimum of 1,400 and up to 2,000 IU a day, and if you are obese, you probably need at least one and a half to two times as much, because the fat sequesters the vitamin D," Holick said. "We now recognize that you can take up to 10,000 IUs a day and not worry about any untoward toxicity."

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Cancer

Symptoms Alone Don't Spot

Ovarian Cancer Early

Researcher notes bloating, stomach pain, fatigue also point to less serious diseases

By Jennifer Thomas
HealthDay Reporter

THURSDAY, Jan. 28 (HealthDay News) -- Relying on symptoms alone to identify women who have ovarian cancer isn't very effective at catching the disease early, a new study indicates.

Research shows that women with ovarian cancer are much more likely than healthy women to report symptoms such as abdominal pain, bloating, feeling full quickly after eating and urinary urgency, especially if the symptoms are relatively new and persistent, said study author Mary Anne Rossing, a member of the Program in Epidemiology at Fred Hutchinson Cancer Research Center in Seattle.

But because ovarian cancer is fairly rare, while the symptoms are relatively common and possibly explained by less serious conditions, the ability to predict who has cancer based on symptoms alone is limited, Rossing said.

Researchers found that for every 100 women in the general population whose symptoms matched those in a widely accepted ovarian cancer symptom index, only one would actually have early-stage ovarian cancer.

"The rarity of ovarian cancer in the general population results in the positive predictive value of these symptoms in detecting ovarian cancer as being quite low," Rossing said. The disease strikes about one in 72 women.

The study is published in the Jan. 28 online issue of the Journal of the National Cancer Institute.

Finding ways to detect early-stage ovarian cancer is an ongoing challenge, said Cara Tenenbuam, vice president of policy and external affairs for the Ovarian Cancer National Alliance.

Ovarian cancer sometimes is found during a pelvic exam, but tumors are often too deep within the body for doctors to detect. In addition, the symptoms of ovarian cancer are often missed or misdiagnosed as other less serious conditions, including menopause, lactose intolerance, irritable bowel syndrome or even depression, Tenenbaum said

While nine of 10 women whose ovarian cancer is caught early are alive five years after diagnosis, only about 20 percent of ovarian cancers are found at their early stage, according to the American Cancer Society.

To address this, in 2007, three major cancer organizations -- the American Cancer Society, the Gynecologic Cancer Foundation and the Society of Gynecologic Oncologists -- released a consensus statement that included a constellation of symptoms women and their doctors should be aware of, including swelling of the stomach or bloating, pelvic pressure or stomach pain and trouble eating.

Rossing and her colleagues interviewed 812 women aged 35 to 74 who had epithelial ovarian cancer, the most common type of ovarian cancer, about their symptoms during the year leading up to diagnosis and compared them to 1,313 who didn't have cancer.

Women who were diagnosed with cancer were 10 times more likely to experience the symptoms than women without cancer, according to the study. Among patients with early-stage disease, about 27 percent experienced the symptoms for at least five months before diagnosis.

Yet the symptoms aren't much use in identifying cases of ovarian cancer in the general population because in 99 out of 100 cases, a women with the symptoms would not have ovarian cancer, Rossing said.

"We need to understand more about the benefits and risks for women who receive evaluations for ovarian cancer because of these symptoms," Rossing said. "Risks may include the worry and expense of unnecessary testing, ultrasound and even unnecessary surgery."

Last year, 21,550 new cases of ovarian cancer were diagnosed among U.S. women; 14,600 deaths were attributed to the disease.

In the absence of more precise screening techniques, Tenenbaum said women and their doctors should be aware of possible signs of ovarian cancer, and women should not hesitate to see their doctors if their symptoms are persistent or are clearly not how they usually feel.

"We talk a lot about symptom awareness, but what this study shows is we still need a reliable early detection test," Tenenbaum said. "The symptoms index is the best we have right now for early detection. You need to know what's normal for you. If it's new for you and you're not feeling good, we want you to have good access to medical care and to avail yourself of it."

Meanwhile, scientists continue to experiment with better detection methods. According to a study in the February issue of the American Journal of Roentgenology, researchers are working on developing better early-stage cancer detection through the use of contrast-enhanced ultrasound combined with blood tests that look for tumor biomarkers.

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Science

Your Body Moves Through

Time With Your Mind

Posture seems to reflect thoughts of past or future, study finds.

THURSDAY, Jan. 28 (HealthDay News) -- When people think back to the past or look toward the future, their body language reflects their sense of time travel, a new study suggests.

Researchers at the University of Aberdeen fitted subjects with motion sensors and asked them to imagine events in the future or the past. The bodies of those who thought about the future actually moved forward. Those who thought about the past swayed backward.

The findings appear online in the journal Psychological Science.

"The embodiment of time and space yields an overt behavioral marker of an otherwise invisible mental operation," the researchers wrote.

More information

The National Institute of Neurological Disorders and Stroke has more on the brain.

(SOURCE: Association for Psychological Science, news release, January 2010)

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Drugs

Approved Drug Products with

Therapeutic Equivalence

Evaluations (Orange Book)

The Orange Book data files are current through December 2009. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files. However, if you detect an error or discrepancy in drug data, please send a brief description of the data problem to the following e-mail address: DRUGPRODUCTS@CDER.FDA.GOV.

General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Drug Information Branch at the following e-mail account: DRUGINFO@FDA.HHS.GOV.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information Staff at:

Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500

The CDER Freedom of Information Office Electronic Reading Room provides background information about the FOI process.

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Alert

Teva Animal Health, Inc. expands a voluntary nationwide recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials

Contact:
Denise Bradley
Tel: 215-591-8974

FOR IMMEDIATE RELEASE -- December 21, 2009 - Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

Ketamine Hydrochloride is a rapid acting, non-narcotic, non-barbiturate agent for anesthetic use in cats and for restraint in subhuman primates. This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

Consumers with questions may contact 800-759-3664 from 8:00am – 5:00pm CST Monday-Friday.

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