December 2009 - FDA News

FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary

FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema
The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug.

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010
As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.

U.S. Attorney News Release: Camano Island Man Indicted for Scheme

U.S. Attorney News Release: Camano Island Man Indicted for Scheme to Steal and Sell Diabetic Supplies
MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment.

CONSERVE Plus Total Resurfacing Hip System The CONSERVE Plus Total

CONSERVE Plus Total Resurfacing Hip System
The CONSERVE Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE Plus Total Resurfacing Hip System is called a resurfacing prosthesis because... (Approved: 11/3/2009)

Faribault Foods Voluntarily Recalls Three Lots of Health Valley Organic

Faribault Foods Voluntarily Recalls Three Lots of Health Valley Organic No Salt Added Split Pea Soup Due to the Presence of an Undeclared Allergen
Faribault Foods announced that it is recalling Health Valley Organic No Salt Added Split Pea Soup (15 oz.) with the lot codes 22JUL2011, 18AUG2011, and 11SEP2011 because of the presence of an undeclared dairy allergen. This soup contains butter and potatoes, which are not listed on the ingredient statements of the affected lots. No other lot codes of this product or any other Health Valley product is affected in any way.

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

USDA and HHS Continue Food Safety Working Group Efforts; Customs

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center
Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States. The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP). It was created on the recommendation of President Obama s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century.

FDA Takes Action Against Maryland Veal Calf Dealer The U.S.

FDA Takes Action Against Maryland Veal Calf Dealer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.

USDA and HHS Continue Food Safety Working Group Efforts; Customs

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center
Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States. The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP). It was created on the recommendation of President Obama?s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century.

TAXUS Libert Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail

TAXUS Libert Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems)
The TAXUS Libert Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 5/21/2009)

College Inn Initiates Voluntary Recall of Select Canned Chicken Broth

College Inn Initiates Voluntary Recall of Select Canned Chicken Broth Products due to Mislabeling
As a precautionary measure, due to mislabeling, College Inn is initiating a voluntary recall of College Inn No MSG Chicken Broth sold in individual 14 oz cans. All other sizes and varieties of College Inn Chicken Broth are correctly labeled and therefore are not affected by this voluntary recall.

Faribault Foods Voluntarily Recalls Three Lots of Health Valley Organic No Salt Added Split Pea Soup Due to the Presence of an Undeclared Allergen
Faribault Foods announced that it is recalling Health Valley Organic No Salt Added Split Pea Soup (15 oz.) with the lot codes 22JUL2011, 18AUG2011, and 11SEP2011 because of the presence of an undeclared dairy allergen. This soup contains butter and potatoes, which are not listed on the ingredient statements of the affected lots. No other lot codes of this product or any other Health Valley product is affected in any way.

Market of Choice Recalls Hazelnuts Because of Possible Health Risks
Market of Choice is recalling bulk and packaged hazelnuts (filberts) that were processed at Willamette Shelling Inc. for Evonuk Oregon Hazelnuts. The nuts were recalled from seven Market of Choice stores in Oregon on December 17.

U.S. Attorney News Release: Former New Hampshire Registered Nurse Pleads

U.S. Attorney News Release: Former New Hampshire Registered Nurse Pleads Guilty for Tampering With Dilaudid and Demerol Syringes at Southern New Hampshire Medical Center
On December 3, 2009, in U.S. District Court, Trinidad Smith, 28, of Manchester, NH, pleaded guilty to an indictment charging her with violations involving consumer product tampering and obtaining a controlled substance by fraud or deception.

FDA Takes Action Against Maryland Veal Calf Dealer The U.S.

FDA Takes Action Against Maryland Veal Calf Dealer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.

FDA Expands Presence Outside U.S. with Opening of Mexico City

FDA Expands Presence Outside U.S. with Opening of Mexico City Post
As part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas, the U.S. Food and Drug Administration today announced the opening of its Mexico City post. This is the Agency s third post in Latin America and its tenth international post in the past 13 months

USDA and HHS Continue Food Safety Working Group Efforts; Customs

USDA and HHS Continue Food Safety Working Group Efforts; Customs and Border Protection Opens Import Food Safety Center
Agriculture Secretary Tom Vilsack and Health and Human Services (HHS) Secretary Kathleen Sebelius today commended the Department of Homeland Security for opening a center devoted to ensuring the safety of foods imported to the United States. The Commercial Targeting and Analysis Center (CTAC) for Import Safety is operating under the direction of Customs and Border Protection (CBP). It was created on the recommendation of President Obama s Food Safety Working Group, which is charged with advising the President on how to upgrade the U.S. food safety system for the 21st century.

U.S. Attorney News Release: Camano Island Man Indicted for Scheme

U.S. Attorney News Release: Camano Island Man Indicted for Scheme to Steal and Sell Diabetic Supplies
MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment.

TAXUS Libert Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail

TAXUS Libert Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems)
The TAXUS Libert Atom? (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 5/21/2009)

Teva Animal Health, Inc. expands a voluntary nationwide recall of

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

Pet Carousel Conducts Nationwide Recall of Beef Hoof Products and Pig Ears Because of Salmonella Risk
Sanger, CA-- Pet Carousel has initiated a recall of all Pig Ears and all varieties of Beef Hoof pet treats because the products may be contaminated with Salmonella. The problem was discovered after FDA testing found positive results for Salmonella in pig ears and beef hoof products.

Simple Foods, Inc. - Undeclared allergen (milk)
Simple Foods, Inc. ISSUES ALLERGY ALERT ON UNDECLARED DAIRY (traces of milk) IN Carob Peanut Butter Cups, Carob Almond Butter Cups, Carob Mint Cr me Cups, Pre-packaged Carob Brown Rice Crunch, Pre-packaged Carob Peanut Butter Squares, Pre-packaged Crispy Carob Peanut Butter Squares, Pre-Packaged Carob Coated Rice Cakes, Pre-packaged Carob Mint Coated Rice Cakes, and Pre-packaged Carob Almond Butter Coated Rice Cakes.

FDA s Woodcock Discusses Pain Management and Drug Safety in Nov.

FDA s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine
An article by Janet Woodcock, M.D., director of the FDA s Center for Drug Evaluation and Research, titled A Difficult Balance Pain Management, Drug Safety, and the FDA, appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.

FDA s Woodcock Discusses Pain Management and Drug Safety in Nov.

FDA s Woodcock Discusses Pain Management and Drug Safety in Nov. 26, 2009 Issue of The New England Journal of Medicine
An article by Janet Woodcock, M.D., director of the FDA s Center for Drug Evaluation and Research, titled A Difficult Balance Pain Management, Drug Safety, and the FDA, appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.

FDA Approves New Drug Treatment for Long-Term Pain Relief after

FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks
The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.