Palo Alto Labs Recalls Dietary Supplements Aspire36 and Aspire Lite.

Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements

Contact:
Palo Alto Labs
customerservice@paloaltolabs.com

FOR IMMEDIATE RELEASE -- Port St. Lucie, FL -- February 28, 2008- Palo Alto Labs, 265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984, announced today that it is conducting a voluntary nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite. Palo Alto Labs is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Sulfoaildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. This may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Aspire36 and Aspire Lite are sold nationwide. The products are sold as a blister pack containing one liquid capsule or a bottle containing either three (3) or twelve (12) liquid capsules.

Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately. In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician right away. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The Company is advising consumers to return any unused Aspire36 and Aspire Lite, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can call 1-(877)240-3340 for instructions on the return and refund process.

Palo Alto Labs conducts stringent quality control testing on both raw materials and finished products. Previous testing protocols did not include a test for the presence of Aildenafil or sulfoaildenafil but Palo Alto Labs assures consumers that this deficiency has been rectified. Palo Alto Labs apologizes for any inconvenience and expresses its concern for the health of consumers by conducting a voluntary recall action. Palo Alto Labs promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

tag: FDA Recall, FDA Recall, Aspire36 Recall, Aspire Lite Recall, Palo Alto Labs Recall, Sildenafil, Aildenafil, Dimethyl sildenafil thione, sulfoaildenafil, male Erectile Dysfunction, MedWatch

Report Links Baxter Heparin to More Deaths

NEW YORK (Associated Press) - A day after Baxter International Inc. recalled nearly all remaining batches of its blood thinner heparin, a report Friday linked the product to additional patient deaths.

Late Thursday, Baxter said it will recall all remaining lots of heparin single- and multi-dose injections and HEP-LOCK products. The company recalled nine production lots of heparin multi-dose injection in January after the drug was linked to four deaths and hundreds of allergic reactions.

On Friday, the New York Times reported that the Food and Drug Administration had discovered possible links to 17 other deaths. The paper added that the agency is focusing on a Chinese plant that supplies the active ingredient in heparin, which is made from mucous membranes extracted from pig intestines.

In a letter posted to the FDA Web site Thursday, the FDA discussed problems in the manufacturing process. It said some lots of heparin sold in the U.S. "included material from an unacceptable workshop vendor," among other issues.

While the FDA investigation is not complete, Goldman Sachs analyst Lawrence Keusch said there was reason to believe the problem was linked to the Chinese plant, Changzhou SPL.

"Baxter and the FDA have ruled out any issues at the company's Cherry Hill, New Jersey, finishing facility," he said. He added that the only form of Baxter's heparin left on the market is a premixed IV solution, which is not sourced from China.

Keusch said the expanded recall is not a surprise, and won't have much impact on Baxter.

"From a financial perspective, heparin sales were roughly $30 million in 2007, and with a gross margin of 20 percent are not material to earnings," he said.

He added the recall is unlikely to affect other Baxter product, because only a few of its minor products are processed in China, and none are made at the facility cited by the FDA.
tag: FDA Recall, drug recall, Changzhou SPL, heparin, HEP-LOCK products, Baxter International recall,

Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) November 2007

This summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

tag: FDA Advisory, Drug Advisory,

Baxter Recalls All Heparin Sodium Injection

Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. The Baxter lots of Heparin was linked to mix up of factory names in China that prevented proper inspection.

• Public Health Update: Recall of Heparin Sodium for Injection (2/28/2008)
• FDA-483 on Heparin (2/28/08)
• Public Health Advisory (2/11/2008)
• Question and Answers (2/11/2008)
• FDA News (2/11/2008)
• Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (2/28/08)
• Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials (1/25/2008)
• Transcript of FDA Press Conference on Adverse Events Associated with Baxter Healthcare Corporation’s Multiple-Dose Vials of Injectable Heparin (2/18/2008 and 2/11/2008)

tag: FDA Recall, Missouri Department of Health, heparin, CDC, Baxter, hemodialysis, photopheresis, Baxter of Deerfield, hypersensitivity, corticosteroids, MedWatch, Multiple-dose Vial Heparin, Baxter Healthcare Corporation

Amylin Pharmaceuticals, Inc. Adds acute pancreatitis to the Byetta's PRECAUTIONS section of the product label.

Byetta (exenatide)

Audience: Endocrinologists, other healthcare professionals, consumers
[UPDATED 02/27/2008] Dear Healthcare Professional letter posted.

[Posted 10/16/2007] FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.

Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

[October 16, 2007 - Information for Healthcare Professionals - FDA]
[October, 2007 - Letter - Amylin Pharmaceuticals, Inc. and Eli Lilly and Company]

tag: FDA Advisory, Drug Advisory, Byetta, acute pancreatitis, type 2 diabetes, type 2 diabetes drug Byetta,

Reports of Clinically Significant Liver Injury With Tysabri (natalizumab)

Tysabri (natalizumab)
Audience: Neurologists, other healthcare professionals, patients
[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

February, 2008 - Letter - Biogen Idec, Elan]
[January, 2008 - Prescribing Information - Biogen Idec, Elan]

tag: FDA Alert, Drug Advisory, Tysabri, natalizumab, Biogen Idec, Elan, liver injury, serum hepatic enzymes, bilirubin,

Nexium Approved for Use in Children Ages 1-11 Years

FOR IMMEDIATE RELEASE February 28, 2008

Media Inquiries: Rita Chappelle, 301-827-6246 Consumer Inquiries: 888-INFO-FDA

FDA Approves Nexium for Use in Children Ages 1-11 Years

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."

Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.

FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.

The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.

Nexium is manufactured by AstraZeneca of Wilmington, DE.

tag: FDA Approval, Drug Approval, Nexium, esomeprazole magnesium, gastroesophageal reflux disease, GERD, CDER, erosive esophagitis, AstraZeneca

Arcalyst, New Orphan Drug for Treatment of Rare Inflammatory Syndromes Approved By FDA

FOR IMMEDIATE RELEASE February 27, 2008

Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
Arcalyst is first treatment for extremely rare condition called Cryopyrin-Associated Periodic Syndrome or CAPS

The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Symptoms of both of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults; however MWS is associated with more severe inflammation and may include hearing loss or deafness. In addition, some MWS patients may also be affected by the buildup of a protein substance that damages organs and tissue (amyloidosis). The FCAS and MWS disorders affect about 300 people in the United States. CAPS disorders are inherited. Fifty percent of CAPS cases are associated with a gene mutation in the CIAS 1 gene.

"Arcalyst offers new promise for this small patient population suffering disorders associated with Cryopyrin-Associated Periodic Syndromes," said Curt Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. "The Orphan Drug Act—now in its 25th year—has been tremendously successful in delivering effective treatments to patients with extremely rare, but serious, diseases."

Arcalyst blocks interleukin-1 which is a signaling protein secreted by certain immune-related cells in the body. Interleukin-1 acts as a messenger to regulate inflammatory responses, but in excess it can be harmful and has been shown to be key in the inflammation seen in CAPS sufferers with FCAS or MWS.

The FDA based its approval on a clinical study conducted by the manufacturer, which demonstrated the drug’s safety and effectiveness. Using a daily diary questionnaire, 47 patients rated the following five signs and symptoms of CAPS: joint pain, rash, feeling of fever/chills, eye redness/pain, and fatigue, each on a scale of zero (none/no severity) to 10 (very severe). Patients noted initial onset of relief of symptoms in their diaries within several days.

The most commonly reported side effects associated with use of Arcalyst were injection-site reactions and upper respiratory infections.

The FDA granted the drug a priority review, which speeds the review process for patients who have unmet medical needs.

Arcalyst is manufactured by Regeneron Pharmaceuticals Inc., Tarrytown, N.Y.

For more information on the Orphan Drug Act, visit: www.fda.gov/orphan/.

tag: FDA Approval, Orphan Drug, Rare Inflammatory Syndrome, Arcalyst, Cryopyrin-Associated Periodic Syndrome, CAPS, rilonacept, Muckle-Wells Syndrome, Familial Cold Auto-Inflammatory Syndrome

Baby Cribs Recalled By Munire Furniture Inc.

Cribs Recall By Munire Furniture Inc.

The Cribs listed below are being recalled. The U.S. Consumer Product Safety Commission announced that the cribs sold by Munire Furniture Inc., of Piscataway, N.J.at Specialty juvenile product stores nationwide from November 2005 through November 2007 for between $400 and $600.
tag: recallr, crib recall, cpsc recall, Munire Furniture Inc recall

Building Baby Safety From the Ground Up

FOR IMMEDIATE RELEASE February 28, 2008 Release #08-203

CPSC Media Contact: (301) 504-7800 CPSC Recall Hotline: (800) 638-2772

WASHINGTON, D.C. - A warm bath, lullaby and bedtime stories are staples in your child’s nighttime routine. The U.S. Consumer Product Safety Commission (CPSC) urges parents and caregivers to add a safe sleep environment to the daily routine of placing baby to sleep.

CPSC staff is aware of 97 crib related deaths from 2002 through 2004.

A CPSC staff analysis (pdf) of reports of deaths related to cribs found that about half of the deaths were in cribs containing pillows, quilts and other bedding. About half of these were due to suffocation when infants ended up face down on pillows or face down in a crib with pillows, quilts and other bedding.

Thirty-percent of crib deaths were attributed to entrapment between components of old cribs that were in bad condition, with broken or missing parts or loose hardware, and entrapment in spaces generated between the sides of a crib and an ill fitted mattress. The remainder of the deaths were associated with accessories situated in/around the crib (such as window cords or curtain tie backs), falls out of cribs, alterations made to cribs, or entrapment when the child became wedged between the crib and other furniture or a wall.

As CPSC works to remove defective products from the marketplace, parents and caregivers are being asked to take action as well.

The CPSC is urging parents:

• To reduce the risk of SIDS and suffocation, place baby to sleep on his or her back in a crib that meets current safety standards
• To prevent suffocation never use a pillow as a mattress for baby to sleep on or to prop baby’s head or neck
• Infants can strangle to death if their bodies pass through gaps generated between loose components, broken slats and other parts of the crib and their head and neck become entrapped in the space.
  • Do not use old, broken or modified cribs
  • Regularly tighten hardware to keep sides firm
• Infants can suffocate in spaces generated between the sides of the crib and an ill fitted mattress; never allow a gap larger than two fingers at any point between the sides of the crib and the mattress
• Never place a crib near a window with blind or curtain cords; infants can strangle on curtain or blind cords.
• Properly set up play yards according to manufacturers’ directions. Only use the mattress provided with the play yard. Do not add extra mattresses, pillows or cushions to the play yard, which can cause a suffocation hazard for infants.
• Routinely check nursery products against CPSC recall lists and remove recalled products from your home
• Sign-up for automatic e-mail recall notifications at www.cpsc.gov

The CPSC has been working since 1973 to improve crib safety with the publication of mandatory standards for full-size cribs and non-full size cribs. CPSC staff has also been involved in the development of voluntary standards for cribs addressing issues such as corner posts and structural and mechanical failures. The work of the CPSC has contributed to an 86% decrease in crib related deaths.

We also list recalls at recallr, a new site dedicated to recalls. We will have links to health and wellness related recalls linked from here. For an example, we just listed a crib recall by Munire furniture Inc.

tag: CPSC Advisory, crib recall, crib deaths, SIDS,

"Beautiful Boy" Author Is Guest Blogger on Drugfree.org

New York, NY, February 26, 2008 – The Partnership for a Drug-Free America is proud to have David Sheff, parent and author of “Beautiful Boy: A Father’s Journey Through His Son’s Addiction,” as a guest blogger on the Partnership’s parent-to-parent blog Decoder (decoder.drugfree.org), which engages the everyday issues of raising healthy, drug-free teens. Sheff’s blog debuts today and he joins a panel of parents who discuss substance abuse, teen culture, current events pertaining to substance abuse and other parenting concerns.

Based on his New York Times Magazine article, “My Addicted Son,” Sheff’s “Beautiful Boy” is an insightful memoir detailing his son Nic’s descent into methamphetamine addiction. Providing a firsthand parent’s perspective on teenage addiction, Sheff’s compelling account has captured the nation’s attention and reveals the overwhelming impact of one family’s struggle to help their son on the road to recovery. Published by Houghton Mifflin, “Beautiful Boy” was selected by Starbucks Entertainment (starbucksentertainment.com/beautifulboy) as the next book to be sold in its more than 7,000 company-operated locations in the U.S. Sheff will embark on a traditional book tour and visit nine local Starbucks across the country to promote his memoir. His first public reading on the tour is February 26 at noon in New York City at the Starbucks at 29th and Park (424 Park Ave South). Starbucks is also helping parent teen communication by promoting tools available on TimeToTalk.org, designed to encourage and support parents and caregivers to have frequent and positive conversations with their teens to keep them healthy.

“I feel grateful for the opportunity to represent a sector of the community whose voice is rarely heard – the parents and families affected by a child’s substance abuse,” said Sheff. “As a parent of a child who struggled with a substance addiction, I went through stages of denial and helplessness and felt like giving up on my son, but I couldn’t. I hope by sharing my experience in ‘Beautiful Boy’ and on the Decoder blog, I’ll have the chance to connect with others who have had or are currently having similar experiences with a loved one’s drug abuse.”

The Partnership for a Drug-Free America is a nonprofit organization uniting communications professionals, renowned scientists and parents. Best known for its national drug-education campaign, the Partnership’s mission is to reduce illicit drug use in America. Now in its 20th year, the Partnership helps parents and caregivers effectively address drug and alcohol abuse with their children. A major new initiative now unfolding integrates the latest science and research with the most effective traditional media and digital communication techniques to give parents the tools, resources and support they need to help their children lead healthy lives. This effort – the first ever for the Partnership – will include a web-based interactive information resource center, parent-to-parent support network, a national toll-free call center and user-friendly online/offline tools. The Partnership depends on donations and support from individuals, corporations, foundations and government. The Partnership thanks SAG/AFTRA for their ongoing generosity.
tag: Health News, My Addicted Son, Beautiful Boy, drugfree.org, Drug-Free America, methamphetamine,

HHS Provides $40 Million in Energy Assistance to Low-Income Families

HHS Secretary Mike Leavitt announced the release of $40 million to help eligible low-income families meet home energy costs. The funds, from the Low Income Home Energy Assistance Program (LIHEAP) emergency contingency fund, will provide 11 states with heating assistance for the winter months.

“Winter weather can have a devastating impact on low-income families,” Secretary Leavitt said, “With these funds, the Bush administration will help ensure that American families are warm during the coldest time of the year.”

LIHEAP helps eligible families pay for home cooling and heating in summer and winter months. Every year, more than 5 million low-income households across the country receive assistance under LIHEAP. The money released today is directed to states with 20 percent of their low-income households using fuel oil as their primary heating source. The Energy Information Administration predicts that average home heating oil expenditures this winter will exceed last year winter’s levels by 34 percent.

“Today’s announcement highlights the Bush administration’s continued commitment to protecting America’s most vulnerable citizens,” said Acting Assistant Secretary for Children and Families Daniel Schneider. “These funds will help many Americans stay warm.”

The release of $40 million brings the total amount of LIHEAP funds released to date to approximately $2.3 billion this fiscal year, including block grant allocations and the $450 million in contingency funds released to all states on Jan. 16, 2008. One-hundred and twenty one million dollars remains available for unanticipated events in the emergency contingency fund.

States receiving emergency contingency funds today include Alaska, Connecticut, Delaware, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island and Vermont.

For a complete list of state allocations of the funds released today go to http://www.acf.hhs.gov/news/press/2008/liheap_allotments_40m.html

Individuals interested in applying for energy assistance should contact their local/state LIHEAP agency. For more information, go to http://www.acf.hhs.gov/programs/liheap/ or http://www.acf.hhs.gov/programs/ocs/liheap/brochure/brochure.html.

tag: LIHEAP, HHS, Low Income Home Energy Assistance Program, Health & Human Services

FDA Advisory: Denture Cleanser Allergic Reactions and Misuse

Denture Cleanser Allergic Reactions and Misuse

Audience: Dental healthcare professionals, patients
[Posted 02/26/2008] FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers. These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both when the product has been used properly as well as from improper use. These events can occur soon after first use or after years of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental healthcare professionals and an 'Advice for Patients' document that can be accessed at the links below.

FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.

[February 25, 2008 - Public Health Notification - FDA]
[February 25, 2008 - Advice for Patients - FDA]

tag: FDA Advisory, dental healthcare, denture cleansers, allergic reactions, persulfate, Public Health Notification

A Brochure That Could save Lives, "My Medicines".

Can carrying around a brochure help save your life? Yes, if it's the "My Medicines" brochure offered by FDA's Office of Women's Health (OWH). It's designed to help consumers track the medications they use.

My Medicines features a chart that allows you to list information about your prescription medicines, including the names of the medicines, how much you take, when you take them, what condition they are treating, and the number of refills.

The brochure also offers advice on how to use labeling information, how to avoid problems with your medicines, and questions you should ask your doctor or pharmacist about your prescriptions.

The brochure is available online at www.fda.gov/womens/taketimetocare/mymeds.html, as well as through the mail and from insurance providers, pharmacies, hospitals, health fairs, senior centers, and other venues.

A Case History

Coral Thomas, a resident of Clarksville, Tenn., is particularly glad that she picked up a My Medicines brochure during a visit to her doctor.

Thomas filled out the brochure, and placed it in her purse. It was there to help her when, at age 66, she suffered a heart attack. "The heart doctor at the hospital told me that (filling out and keeping the brochure) was the smartest thing I could have done," she reported.

Seeing that Thomas was taking daily treatments for high blood pressure and other conditions, the doctor changed his treatment plan. He later told Thomas he wished that every patient would carry such a list because it helps caregivers know the best way to proceed.

After her recovery, Thomas ordered dozens more My Medicines brochures and distributed them to her friends. "It's just the best thing to have," she says. "Women should carry one in their purses and keep a spare in their cars. Believe me, it can save your life."

Of course, the brochure can prove helpful to men as well.

Take Time to Care

My Medicines, which is available in 14 languages, is part of an outreach initiative called "Take Time to Care" (TTTC), which was launched by OWH in 1998 to provide reliable, science-based health information. Millions of My Medicine brochures have been distributed since the program's launch.

OWH now offers more than 50 easy-to-read publications that include fact sheets and medication guides. The following free materials, which are also available in many languages, can be downloaded at www.fda.gov/womens/pubs.html

Use Medicines Wisely

www.fda.gov/womens/taketimetocare/usemeds.html

Take Time To Care About Diabetes
www.fda.gov/womens/taketimetocare/diabetes/default.htm

Menopause and Hormones
www.fda.gov/womens/menopause/default.htm

For More Information

To order "My Medicines" through the mail, visit:
www.pueblo.gsa.gov/results.tpl?id1=16&startat=1&--woSECTIONSdatarq=16&--SECTIONSword=ww

Or call the Federal Citizen Information Center toll-free at 1-888-878-3256 and order publication 556R.

Free Publications for Women and Their Families
www.fda.gov/womens/pubs.html

FDA Office of Women's Health
www.fda.gov/womens/

tag: Medicine, food safty, FDA Services, Women's Health, prescription medicines, My Medicines brochure, high blood pressure, Take Time to Care, Menopause

Breast Cancer Test Is Effective, FDA

The first molecular-based laboratory test for detecting whether breast cancer has spread (metastasized) to nearby lymph nodes was approved by FDA on July 16, 2007. The GeneSearch BLN Assay, manufactured by Veridex, a Johnson & Johnson Company, of Warren , N.J., detects molecules that are abundant in breast tissue but scarce in a normal lymph node.

The Importance of Lymph Nodes

Lymph nodes are part of the system that helps protect the body against infection. The first lymph node that filters fluid from the breast is called the “sentinel node,” because that is where breast cancer cells are likely to spread first.

The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide the appropriate treatment for a woman with metastatic breast cancer.

“The GeneSearch BLN Assay offers a new approach to sentinel node testing,” says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. “Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation.”

During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination under a microscope. Sometimes the sentinel node is examined immediately, and if tumor cells are found, additional lymph nodes are removed.

A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the woman may require a second surgery to remove the remaining lymph nodes.

Test Effectiveness

In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 women. The test accurately predicted nearly 88% of the time that breast cancer had spread in women with metastasis. Women without metastasis were identified accurately 94% of the time.

FDA Press Release (July 16, 2007)

Date Posted: July 17, 2007

tag: breast cancer, GeneSearch BLN Assay, Veridex, Lymph nodes, sentinel node, tumor cells, FDA, metastasis,

New and Generic Drug Approvals, February 21, 2008

• New and Generic Drug Approvals
  • ARESTIN (minocycline hydrochloride) Microspheres, OraPharma Inc., Labeling Revision
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharma, Labeling Revision
  • Avelox (moxifloxacin hydrochloride in NaCl) I.V., Bayer Pharma, Labeling Revision
  • Irinotecan Hydrochloride Injection, Watson Labs, Approval
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Pramipexole Dihydrochloride Tablets, Barr Labs, Approval
  • Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb, Labeling Revision
  • Ultram ER Extended-Release Tablets, Biovail Labs, Labeling Revision

tag: FDA Approval, Drug Approval, Ultram, Reyataz, Pramipexole, Lexiva, Irinotecan, Avelox, Avelox, ARESTIN

Grassplot brand Dried Pachyrhizus Recalled By Lion Pavilion LTD.

Another food product from China recalled;Lion Pavilion LTD. Recalls Grassplot brand Dried Pachyrhizus
tag: FDA Recall, food recall, Recallsglobal,

Xyntha, New Hemophilia Treatment Licensed By FDA

FOR IMMEDIATE RELEASE February 21, 2008

Media Inquiries: Peper Long, 301-827-0599 Consumer Inquiries: 888-INFO-FDA

FDA Licenses New Hemophilia Treatment

The U.S. Food and Drug Administration today licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.

Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.

Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.

"This product provides an additional treatment option for hemophilia A patients. This recombinant Factor VIII is produced without additives from human or animal material, which further minimizes any risk of infection from the product," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.

In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were considered mild or moderate in severity.

In addition, two of 89 individuals who received 50 days of treatment with Xyntha, developed factor VIII inhibitors, which are antibodies that counteract treatment with factor VIII.

Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.

tag: FDA Approval, FDA License, Hemophilia Treatment, hemophilia A, blood-clotting disorder, Xyntha Antihemophilic Factor (Recombinant) Plasma, anti-hemophilic factor, Xyntha, Wyeth Pharmaceuticals Inc.,

FDA Announces Permanent Injunction against Brownwood Acres Foods Inc., And Cherry Capital Services Inc.

FDA Announces Permanent Injunction against Food Companies, Executives
Claim products cure various health conditions

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as "Chemicals found in Cherries may help fight diabetes." The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products' label and labeling comply with the law.

Under the terms of the consent decree, the companies have agreed to remove drug and unauthorized health claims from their labels, brochures, and Web sites, as well as references to other Web sites that contain such claims. They have also agreed to hire an independent expert to review the claims they make for their products and to certify that they have omitted all violative claims.

"The FDA will not tolerate unsubstantiated health claims that may mislead consumers," said Margaret O’K. Glavin, associate commissioner for regulatory affairs. "The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."

Brownwood Acres Foods Inc. and Cherry Capital Services Inc. manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules.

The companies have a history of promoting unapproved claims on their product labels, brochures, and Web sites, stating that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies' Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres' president and contained similar unproven statements claiming benefits for their products.

The FDA can order the companies to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the federal Food, Drug, and Cosmetic Act or FDA regulations. The companies are also required to pay $1,000 per violation per day in the event they fail to comply with the consent decree.

The decree was signed by Judge Paul Maloney on Feb. 19 in the U.S. District Court for the Western District of Michigan.

tag: FDA Action, Flavonoid Sciences, Brownwood Acres Foods Inc., Cherry Capital Services Inc., juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, salmon oil capsules

Mayfield Vanilla Classic Ice Cream Recalled

Another ice cream recall
Mayfield Vanilla Classic Ice Cream Recalled By Mayfield Dairy Farms

tag: FDA Recall, food recall, Recallsglobal, Mayfield Vanilla Classic Ice Cream Recall

Pierre’s Ice Cream Company Recalls Ice Cream

Recallsglobal is reporting that Pierre’s Ice Cream Company Recalls Homestyle Brand of Dutch Chocolate Ice Cream



tag: FDA Recall, Food Recall, Pierre’s Ice Cream Company recall, Homestyle Brand of Dutch Chocolate Ice Cream

RecallsGlobal.com Acquired

RecallsGlobal.com (not live yet) was Acquired by our team to handle recall news and information related to recalls. The amount of recalls have taken major part of our reporting here at Meddesktop, which we are/were glad to do. We were concerned with children health as so many products were recalled due to lead paint violations. Most of these were Chinese Toys or manufactured in China following US Toy makers requests. But this extended to reporting more recalls as it was hard for us to draw lines regarding which and which is not health related recalls.
Since MedDesktop need to cover the general medical news and health news, we will use Recallsglobal.com to let you know about the recalls, every sort of recalls, from every corner of the world.
Wish Us Luck!
tag: Recallsglobal, Recalls, toy recalls, products recalls, recall news

New CPSC Recalls: children’s necklaces, Memory Testing Cards

Family Dollar Recalls Magnetic Dart Boards; Ingested Magnets Pose Aspiration and Intestinal Hazards

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Family Dollar, of Charlotte, N.C., is voluntarily recalling about 250,000 FUN ‘N SAFE Magnetic Dart Boards. Small magnets at the ends of the darts can detach. Magnets found by young children can be swallowed or aspirated. If more than one magnet is swallowed, the magnets can attract each other and cause intestinal perforations or blockages, which can be fatal.

Children’s Metal Jewelry Recalled by Pecoware Due to Risk of Lead Exposure

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Pecoware Co. Inc., of Chino, Calif., is voluntarily recalling about 2,900 Children’s Metal Necklaces. The children’s necklaces contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Children’s Memory Testing Cards Recalled by Riverside Publishing Due to Violation of Lead Paint Standard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Riverside Publishing Co., of Rolling Meadows, Ill., is voluntarily recalling about 5,300 Memory Testing Cards (sold as part of educational testing kits). Surface paint on the cards contains excessive levels of lead, violating the federal lead paint standard.

Rinnai Recalls Wall Furnaces Due to Carbon Monoxide Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Rinnai America Corp., of Peachtree City, Ga., is voluntarily recalling about 52,000 Direct-Vent Wall Furnaces, Models RHFE 431 and RHFE 556. A gasket in the unit can fail, posing a risk of poisonous carbon monoxide gas leaking into the home.

Greenheck Fan Recalls Indirect Gas Fired Furnaces Due to Risk of Fire

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Greenheck Fan Corp., of Schofield, Wis., is voluntarily recalling about 1,500 Indirect Gas-Fired Furnaces. The ignition control module can fail preventing the unit from shutting down in high temperature conditions. This poses a risk of fire, as well as hazardous fumes being released from burning/melting insulation.

Portable Electric Heaters Recalled by Aloha Housewares Due to Fire Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Aloha Housewares Inc., of Arlington, Texas, is voluntarily recalling about 152,000 Portable Electric Heaters. The portable electric heater can overheat and melt plastic parts, posing a fire hazard to consumers.

Louisville Ladder Recalls Extension Ladders Due to Fall Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Louisville Ladder Inc., of Louisville, Ky., is voluntarily recalling about 25,000 “Louisville/Davidson” and “Michigan” Brand Fiberglass Extension Ladders. The extension or “fly” section can fail to lock, posing a fall hazard to consumers.

tag: CPSC recall, Fiberglass Extension Ladders recall, Louisville Ladder Inc. recall, Aloha Housewares Inc.Recall, Portable Electric Heater Recall, Greenheck Fan Corp Recall, Gas-Fired Furnace recall, Rinnai America Corp Recall, Direct-Vent Wall Furnace Recall, Riverside Publishing Recall, Memory Testing Cards Recall

The Deloitte survey : U.S. Consumers Want Major Changes in Health Care Design, Delivery

WASHINGTON, D.C., February 20, 2008 – American consumers want more from their health care system than they’re currently getting – greater online connection to health care providers and medical records, customized insurance coverage and wider access to emerging innovations such as retail clinics, a new survey from Deloitte reveals.

At the same time, they express anxiety about future health care costs – only 7 percent say they’re adequately prepared financially – and increasingly search for alternative medicines and services that can save them money and offer convenience. But many also say they are willing to pay extra for wellness programs, and to support or consider tax increases to cover the uninsured.

The 2008 Survey of Health Care Consumers, a representative poll of more than 3,000 Americans between the ages of 18 and 75, was conducted by the Deloitte Center for Health Solutions. It was directed by Paul Keckley, executive director of the Deloitte Center for Health Solutions, and William Copeland, Jr., national managing director of the Life Sciences and Health Care practice of Deloitte Consulting LLP.

“More than anything, the findings convince us that Americans no longer see themselves only as patients, but as consumers who want to take greater control of their health care,” Keckley said. “Consumers will redefine our health care market, but how they do it is the most important strategic question the health care industry must answer.”

Copeland said the survey’s scope makes it one of the most thorough and comprehensive efforts to date to measure consumer attitudes, behaviors and unmet needs. “We believe these attitudes and consumer demands could have a transformative impact on the way health care services and products are developed,” he said.

Among the survey’s key findings:

• 93 percent say they are not well prepared for future health care costs
• 79 percent of consumers believe health care will be an important issue in the 2008 election; 46 percent described it as one of the top three issues affecting their vote
• 34 percent say they would use a retail clinic; 16 percent already have
• 60 percent want physicians to provide online access to medical records and test results, and online appointment scheduling; one in four say they would pay more for the service
• 1 in 3 consumers say they want more holistic/alternative therapies in their treatment program
• 3 of 4 consumers want expanded use of in-home monitoring devices and online tools that would reduce need for visits and allow individuals to be more active in their care
• 2 in 5 consumers want a wellness program to improve health and/or save money; one in four say they would pay more for it
• 84 percent prefer generic drugs to name brands
• 29 percent support a tax increase to help cover the uninsured; another 34 percent say they would consider a tax hike
• 52 percent of consumers say they understand their insurance coverage; only 8 percent understand their policies completely
• For additional findings, visit www.deloitte.com/us/consumerism/library

The way Americans think and behave in buying, managing and using their health care varies widely by gender, age group and cultural background, according to the survey. Women and men, for instance, have very different approaches to how they select and pay for their health care.

The Deloitte survey, however, found that consumer needs overall are basic -- better service, personalization, value – and that they want specific tools to customize the health services and insurance programs they use. Consumers are embracing innovation. Respondents said they wanted health plans to provide help with clinical decisions, not simply administrative services, and many want to customize their insurance with unique coverage and pricing features.

In addition, the survey revealed the consumer health care market is not homogenous; key distinctions exist within different groups. An analysis of the data found that the more than 3,000 respondents fell into six discrete segments, ranging from “content and compliant” consumers more accepting of the status quo to “out and about” health care shoppers who tend to be more independent and willing to try unconventional treatments.

Those factors taken together carry with them the potential for dramatic near-term change in the way U.S. doctors, hospitals, health plan administrators, drug makers and biotech companies operate, Keckley noted.

For general information on the survey, please contact Scott Ladd. For information on the Health Plans, Health Providers, and Life Sciences practices of Deloitte, please contact Marykate Reese.

tag: health care, Medical News, Deloitte Center for Health, medical records, insurance coverage, health care costs, Deloitte survey,

Google, Cleveland Clinic Teams On A Pilot To Manage Medical Records

Alan Newberger, of Google has a post about his thoughts on building tools that will help manage personal health information more effectively. Google recently entered into an agreement with The Cleveland Clinic. A large academic medical center, to run a pilot program to manage patient records more effectively.
"Cleveland is just the first of many healthcare providers that will securely send medical records and information via Google APIs at your request. We've been hard at work collaborating with a number of insurance plans, medical groups, pharmacies and hospitals. While this pilot is open initially to just a few thousand patients, I see it as an important first step to show how Google can help users get access to their medical records and take charge of their health information."
Official Google Blog: A pilot with the Cleveland Clinic for health information access
tag: google health, patient records, The Cleveland Clinic, Gdata

Secretary of Agriculture's Statement Regarding Hallmark/Westland Meat Packing Company.

Statement by Secretary of Agriculture Ed Schafer Regarding Hallmark/Westland Meat Packing Company Two Year Product Recall
February 17, 2008


"Today, USDA is announcing additional actions as a result of the ongoing investigation at Hallmark/Westland Meat Packing Company. USDA's Food Safety and Inspection Service (FSIS) has evidence that Hallmark/Westland did not consistently contact the FSIS public health veterinarian in situations in which cattle became non-ambulatory after passing ante-mortem inspection, which is not compliant with FSIS regulations. Because the cattle did not receive complete and proper inspection FSIS has determined them to be unfit for human food and the company is conducting a recall.

The United States enjoys one of the safest food supplies in the world. To help ensure the safety of the food supply, we implement a series of safeguards to protect against foodborne disease. These safeguards include in-plant procedures to reduce dangerous foodborne pathogens such as E. coli O157:H7 and Salmonella. It also includes the removal of specified risk materials-those tissues demonstrated to contain the bovine spongiform encephalopathy agent in infected cattle-from the human food chain, along with the U.S. Food and Drug Administration's 1997 ruminant to ruminant feed ban. The prohibition of non-ambulatory cattle from the food supply is an additional safeguard against bovine spongiform encephalopathy.

Upon notification of possible violations of USDA regulations, we immediately began an investigation and placed products from this plant destined for the National School Lunch Program, the Emergency Food Assistance Program and the Food Distribution Program on Indian Reservations on hold. Since then, we also suspended all Federal food and nutrition program contracts with Hallmark/Westland Meat Packing Company. To date, Hallmark/Westland Meat Packing Company remains suspended by the Food Safety and Inspection Service. The products destined for the Federal food assistance programs, including the National School Lunch Program, will now be removed from schools and other holding facilities and destroyed.

I am dismayed at the in-humane handling of cattle that has resulted in the violation of food safety regulations at the Hallmark/Westland Meat Packing Company. It is extremely unlikely that these animals were at risk for BSE because of the multiple safeguards; however, this action is necessary because plant procedures violated USDA regulations.

In addition, our Office of the Inspector General and the Food Safety and Inspection Service continue the investigation. We will respond immediately if further findings warrant. Details about this recall and USDA actions are available at www.usda.gov/actions . "

tag: Beef Recall, USDA recall, Hallmark/Westland Meat Packing Company, Hallmark/Westland Meat Recall, Secretary of Agriculture, FSIS regulations, FSIS, foodborne disease,

Government Looks At Meat Production After Larget Meat Recall In History.

WSJ is reporting that Lawmakers and government investigators seized on the largest meat recall in U.S. history to set the table for changes in the nation's food-safety system, especially as it applies to school lunches.

Rep. Rosa DeLauro, the Connecticut Democrat who heads a House subcommittee overseeing the Agriculture Department's budget, scheduled two food-safety hearings for March, at which top department officials are expected to testify. Wisconsin Democratic Sen. Herb Kohl, chairman of a subcommittee on agriculture appropriations, has tentatively scheduled a hearing for Feb. 28. Meanwhile, Congress's investigative arm, the Government Accountability Office, plans to look at food safety in the federal school-lunch program, which is run by the Agriculture Department.

The House Energy and Commerce Committee, whose investigators have studied food-safety issues for more than a year, has invited top executives from a half-dozen food processors, including the president of Hallmark/Westland, to a hearing Tuesday on the beef recall and other safety issues.

Under rules designed to prevent mad-cow disease, meat companies are required to report downer cows to federal authorities. An Agriculture Department rule, finalized in July 2007, allows federal veterinarians to make a case-by-case decision on such cattle; some cattle, such as those with a broken leg, are still likely to be slaughtered for meat.

But businesses don't always follow the rules. In a 2006 report, the Agriculture Department's inspector general found that most companies visited didn't have adequate plans to reduce the risk of transmitting mad-cow disease, and that the department "did not always identify these deficiencies."

tag: Beef Recall, mad-cow disease, Hallmark/Westland, Agriculture Department,

Mix Up Of Names Prevented Chinese Heparin Factory Inspection, FDA

Chinese Factory Linked to Drug Heparin?

That we reported last week as well as Baxter recall, the factory has not been inspected by FDA due to mixup of names. FDA has mistakenly assumed that the factory was earlier inspected while it was not. The FDA's explanation, by Joseph Famulare, deputy director of compliance for the FDA's center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA's inspection procedures for drugs entering the U.S. from China.
source

tag: FDA, Heparin,

Spiderman Water Bottles, Cinderella Battery-Powered Toy Cars Recalled

Spiderman Water Bottles Sold Exclusively at Sears Recalled by Fast Forward Due to Choking Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Fast Forward LLC, of New York, N.Y., is voluntarily recalling about 6,600 Spiderman® Water Bottles. Screws under the bottle’s lid can come loose and fall into the cup, posing a choking hazard to children.

Cinderella Battery-Powered Toy Cars Recalled by Dumar International USA Due to Fire and Burn Hazards

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Dumar International USA, of Franklin, Mass., is voluntarily recalling about 64,000 Cinderella 12-Volt Electric Ride-On Vehicles. The wires under the hood of the car and/or in the battery compartment under the seat can short circuit, posing a fire and burn hazard to children riding in the car.

tag: CPSC recall, Spiderman Water Bottles recall, sears recall, Dumar International USA recall, toy recall, Cinderella 12-Volt Electric Ride-On Vehicle recall

Actavis Recalls Certain Fentanyl Patches

Actavis Recalls Certain Fentanyl Patches in the US as Precaution
Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

Media Contact:
Actavis Inc.
Sarita Thapar, PharmD
908-659-2471

FOR IMMEDIATE RELEASE -- Morristown, NJ -- February 17, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.

The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl patches sold by Actavis in Europe are not affected by this recall.

The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these lot numbers.

Affected patches should not be handled directly.

Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877 422 7452.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

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 website at www.fda.gov/medwatch.

tag: FDA Recall, Fentanyl transdermal, Fentanyl Patches recall, Actavis' CII patches recall, Actavis South Atlantic LLC, Corium International Inc., opioid medication recall, fentanyl gel, Abrika Pharmaceuticals Inc recall

Mission City Press Recalls Girl's Bracelet

Mission City Press Recalls Girl's Bracelet Sets Due to Violation of Lead Paint Standard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Mission City Press, of Franklin, Tenn., is voluntarily recalling about 11,000 A Life of Faith Charm Bracelet Sets. Surface paint on the pearl white beads of the bracelet, contains excessive levels of lead, violating the federal lead paint standard.

tag: CPSC recall, Mission City Press recall, lead paint violation, A Life of Faith Charm Bracelet Set recall

Bassettbaby Drop-Side Cribs Sold By Babies "R" Us stores Recalled Due to Entrapment and Strangulation Hazard

Bassettbaby Drop-Side Cribs Recalled Due to Entrapment and Strangulation Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Bassettbaby, of Bassett, Va., is voluntarily recalling about 18 Wendy Bellissimo Hidden Hills Collection Drop-Side Cribs. Spindles on the drop-side of the crib could loosen creating a gap that poses an entrapment and strangulation hazard.
The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Wendy Bellissimo Hidden Hills Collection Drop-Side Cribs

Units: 18

Importer: Bassettbaby, of Bassett, Va.

Hazard: Spindles on the drop-side of the crib could loosen creating a gap that poses an entrapment and strangulation hazard.

Incidents/Injuries: Bassettbaby has received three reports of spindles coming loose. No injuries have been reported.

Description: This recall involves a full-size, drop-side crib from the Wendy Bellissimo Hidden Hills collection, model number 5446-0504. The model number is located on the bottom rail of the headboard. The crib was sold in a Navajo Pine finish. No other models are included in this recall.

Sold at: Babies "R" Us stores nationwide from November 2007 through January 2008 for about $400.

Manufactured in: China

Remedy: Consumers should stop using the crib immediately and contact Bassettbaby for a free replacement or a full refund. The firm has contacted consumers directly.

Consumer Contact:For additional information, contact Bassettbaby toll-free at (800) 308-7485 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.bassettbaby.com

tag: Entrapment and Strangulation Hazard, Bassettbaby Drop-Side Cribs Recall, Bassettbaby recall, Crib recall, Wendy Bellissimo crib recall, Babies "R" Us

Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled"

Nutri-Foods Recalls "Organic Sesame Seeds Natural - Unhulled" Because of Possible Health Risk

Contact:
John Bettin
248-541-6820

FOR IMMEDIATE RELEASE -- February 15, 2008 -- Nutri-Foods, Inc. ("Nutri-Foods") of Royal Oak, Michigan, is recalling its .50 pound packages of "Organic Sesame Seeds Natural - Unhulled" due to possible salmonella contamination, 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 illness such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The recalled "Organic Sesame Seeds Natural - Unhulled" were sold at Nutri-Foods.

The product comes in a .50 pound clear plastic package with a product SKU #170 at the top and a "packed on" date of December 28. This product was sold from circa December 15, 2007 through January 28, 2008.

No illnesses have been reported to date in connection with this problem.

Production of the product has been suspended while the FDA and manufacturer of the product continue their investigation.

Consumers who have purchased the .50 pound package are urged to return them to Nutri-Foods for a full refund. Consumers with questions may call Nutri-Foods at (248) 541-6820 and ask for John B. or Judy.

tag: FDA Recall, food recall, Salmonella contamination, Nutri-Foods Recall, Organic Sesame Seeds recall,