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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 5 Mar 2008 06:05:31 -0600 (CST)
Subject: Limited Number of Aunt Jemima Pancake and Waffle Mix Products Recalled for Possible Health Risk (March 4)
Limited Number of Aunt Jemima Pancake and Waffle Mix Products Recalled for Possible Health Risk (March 4)
Wed, 5 Mar 2008 04:42:00 -0600
The Quaker Oats Co. announced the products in the recall are a small quantity of Aunt Jemima Pancake and Waffle Mix: Original, Original Complete and Buttermilk Complete, which may have potential salmonella contamination. No other Aunt Jemima, frozen Aunt Jemima or Quaker products are affected.
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 5 Mar 2008 09:05:50 -0600 (CST)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 5 Mar 2008 10:05:33 -0600 (CST)
Subject: New BCN Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Asian Boy Sweet Ginger (Feb. 11)
New BCN Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Asian Boy Sweet Ginger (Feb. 11)
Wed, 5 Mar 2008 08:42:00 -0600
New BCN Trading Inc. of South Plainfield, NJ is recalling 7 oz. plastic tubs of Asian Boy Brand Dried Ginger because the product contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life threatening allergic reactions if they consume this product. No illnesses have been reported to date in connection with this product. The Asian Boy Brand Dried Ginger, a product of Vietnam, was distributed to retail stores in NJ, NY, FL, MD, VA, CT, MA, OH and PA in an uncoded 7 oz. plastic tub.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 5 Mar 2008 18:21:34 -0600 (CST)
Subject: FDA Update for Health Professionals - March 5, 2008
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, announcements, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION
Media Briefing (Mar 5)
FDA held a media briefing to provide an update on the FDA’s investigation into severe allergic reactions associated with heparin products made by Baxter Healthcare Corporation. Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs and Janet Woodcock, M.D., Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and Acting Director of the FDA’s Center for Drug Evaluation and Research gave brief comments. Presentations were followed by a question and answer session.
A replay of the briefing will be available starting at 3 p.m. on March 5 through March 12. To hear the replay, callers in the United States can dial 800-944-1518; international callers 1-203-369-3416.
Limited Number of Aunt Jemima Pancake & Waffle Mix Products Recalled for Possible Health Risk (Mar 4)
The Quaker Oats Co. announced the recall of a small quantity of Aunt Jemima Pancake & Waffle Mix: Original, Original Complete and Buttermilk Complete, which may have potential salmonella contamination. No other Aunt Jemima, frozen Aunt Jemima or Quaker products are affected.
Salmonella is a food borne illness that 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, nausea, vomiting and abdominal pain.
Actavis Recalls Remaining Fentanyl Patches in the U.S. as Precaution (Mar 1)
Actavis Inc., of Morristown, New Jersey, announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States. This recall is an expansion of the Company's initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.
Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products (Feb 28)
Baxter International Inc., of Deerfield, Illinois announced that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.
Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements (Feb 28)
Palo Alto Labs of Port St. Lucie, Florida, announced 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.
Walker's Food Products Company Recalls Four Bean Salad Because Of Possible Health Risk (Feb 28)
Walker's Food Products Company of North Kansas City, Missouri, is recalling its 16oz., 5-lb. and 10-lb. containers of Four Bean Salad because of potential contamination with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product, even if it does not look or smell spoiled. Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double vision, and trouble with speaking or swallowing. Difficulty in breathing, weakness of muscles, abdominal distension, and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.
PRODUCT APPROVALS:
FDA Approves Nexium for Use in Children Ages 1-11 Years (Feb 28)
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.
FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
(Feb 27)
The U.S. Food and Drug Administration 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).
FDA Licenses New Hemophilia Treatment (Feb 21)
On February 21, 2008, the U.S. Food and Drug Administration 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.
For a complete description of approvals of FDA-regulated products, please visit http://www.fda.gov/opacom/7approvl.html
RECENT ANNOUNCEMENTS:
FDA Announces Permanent Injunction against Food Companies, Executives (Feb 22)
The U.S. Food and Drug Administration 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.
UPCOMING MEETINGS:
Oncologic Drugs Advisory Committee
DATE AND TIME: March 12-13, 8:00 a.m.
LOCATION: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave., Gaithersburg, MD
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, 301-827-6793. More Information
Pediatric Advisory Committee
DATE AND TIME: March 25, 8:00 a.m.
LOCATION: Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner, 301-827-3340. More Information
DATE AND TIME: April 6-8, 8:00 a.m.
LOCATION: Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD
CONTACT: Norman Stockbridge, Center for Drug Evaluation and Research, (301) 796-2240. More Information
DATE AND TIME: April 10-11, 9:00 a.m. (8:00 on the 11th)
LOCATION: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, 301-827-0314.
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below. If you do not wish to receive this information updates, you may unsubscribe at this link: FDA Consumer Health Information .
Sincerely,
Brenda L. Evelyn, SBB(ASCP) Janelle Derbis, PharmD
Office of Special Health Issues Office of Special Health Issues
U.S. Food and Drug Administration U.S. Food and Drug Administration
5600 Fishers Lane, Room 9-49 20 N. Michigan Avenue, Suite 510
Rockville, MD 20857 Chicago, IL 60602
(301) 827-4460 (312) 596-6516
(301) 443-4555 (fax) (312) 886-1682 (fax)
Brenda.evelyn@.fda.hhs.gov Janelle.derbis@fda.hhs.gov
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