November 2009 - FDA News

FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc. The

FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.
The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigerated can result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.

U.S. Attorney News Release: Computer Salesman Pleads Guilty to Misbranding

U.S. Attorney News Release: Computer Salesman Pleads Guilty to Misbranding a Drug and Copyright Infringement
Ming Yan, who operates a computer store in North Providence, has pleaded guilty to causing the misbranding of the prescription drug sildenafil citrate, which is marketed as Viagara, and to copyright infringement. Immigration and FDA agents seized counterfeit sildenafil citrate pills and more than 1,000 pirated movie DVDs from Yan?s store and home in March 2008.

FDA Clears First Rapid Test for Bacterial Contamination in Pooled

FDA Clears First Rapid Test for Bacterial Contamination in Pooled Platelets
The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.

TAXUS Liberte? Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary

TAXUS Liberte? Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the Wire Delivery Systems)
The TAXUS Liberte? Long (2.75?4.00 mm x 38 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: 7/13/2009)

Nassau Candy Issues Nationwide Allergy Alert Because Of Possible Undeclared

Nassau Candy Issues Nationwide Allergy Alert Because Of Possible Undeclared Allergens on their Tasty Dish Snack Tubs of Chocolate Almonds, Chocolate Raisins and Sour Neon Worms
Nassau Candy Distributors of Hicksville, New York, is voluntarily recalling possibly unlabeled pegable snack tubs because they contain the following undeclared allergens; Tree Nuts {Almonds}, Soy and Milk and may contain the following undeclared allergens Peanuts, other Tree Nuts {brazil nuts, walnuts, filberts, hazelnuts, pecans, pistachios, macadamia nuts, cashews and coconut}. People who have an allergy to any of these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products...

IDS Sports Conducts a Voluntary Nationwide Recall of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR
IDS Sports announced today that it is conducting a voluntary nationwide recall of five of the company s dietary supplement products sold under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR. The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the following undeclared substances, which FDA considers to be steroids: Madol, Turinabol, Superdrol, and/or Androstenedione.

FDA To Look Into Safety of Caffeinated Alcoholic Beverages The

FDA To Look Into Safety of Caffeinated Alcoholic Beverages
The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

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.

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.

FDA Issues 22 Warning Letters to Web site Operators The

FDA Issues 22 Warning Letters to Web site Operators
The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

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)

Cardiovascular Systems Initiates Voluntary Recall of ViperSheathTM Sheath Introducer ?

Cardiovascular Systems Initiates Voluntary Recall of ViperSheath^TM Sheath Introducer
? Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheathTM Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall
Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.

FDA To Look Into Safety of Caffeinated Alcoholic Beverages The

FDA To Look Into Safety of Caffeinated Alcoholic Beverages
The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

FDA Approves Lysteda to Treat Heavy Menstrual Bleeding The U.S.

FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

New Report Recommends Enhanced Food Tracing Guidelines The Food and

New Report Recommends Enhanced Food Tracing Guidelines
The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) today released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems.

FDA Takes Action Against Dairy Farm and Owner On Nov.

FDA Takes Action Against Dairy Farm and Owner
On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs.

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)

Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device

Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction
Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device?s periodic self-tests.

PetSmart Voluntarily Recalls Dentley?s Beef Hooves
PetSmart (NASDAQ: PETM) is voluntarily recalling two Dentley?s Beef Hoof products for potential salmonella contamination. The products were manufactured by Pet Carousel, Inc. in Sanger, Calif.

Nassau Candy Issues Nationwide Allergy Alert Because Of Possible Undeclared Allergens on their Tasty Dish Snack Tubs of Chocolate Almonds, Chocolate Raisins and Sour Neon Worms
Nassau Candy Distributors of Hicksville, New York, is voluntarily recalling possibly unlabeled pegable snack tubs because they contain the following undeclared allergens; Tree Nuts {Almonds}, Soy and Milk and may contain the following undeclared allergens Peanuts, other Tree Nuts {brazil nuts, walnuts, filberts, hazelnuts, pecans, pistachios, macadamia nuts, cashews and coconut}. People who have an allergy to any of these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products...

FDA Takes Action Against Dairy Farm and Owner On Nov.

FDA Takes Action Against Dairy Farm and Owner
On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs.

FDA Issues 2009 FDA Food Code Updated code is a

FDA Issues 2009 FDA Food Code
Updated code is a model for state, city, county, tribal, territorial agencies and industry. The Food and Drug Administration today announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. The 2009 FDA Food Code is a key component of the President s overall public-health-focused food safety framework for maintaining a safe food supply.

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.