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FDA, FTC Issue Joint Warning Letter to Web Site Offering


FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements
On October 15, 2009, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus.

FDA, FTC Issue Joint Warning Letter to Web Site Offering


FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements
On October 15, 2009, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus.

U.S. Attorney News Release: Charity Operator Pleads Guilty in a


U.S. Attorney News Release: Charity Operator Pleads Guilty in a Scheme Involving Prescription Drugs That Had Been Donated to Assist the Poor in Developing Countries
Joseph Egbe, age 44, of Gwynn Oak, Maryland, pleaded guilty today to misbranding of pharmaceuticals, announced United States Attorney for the District of Maryland Rod J. Rosenstein.

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)

Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators McAllen,


Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators
McAllen, Texas, October 06, 2009 Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160.

Hannaford Announces Removal of Frozen Taste of Inspirations Vegetable Spring Rolls
Hannaford Supermarkets has taken the precaution of removing Taste of Inspirations Vegetable Spring Rolls from its freezer cases because the rolls may contain shrimp, which was not listed on the ingredient panel. No illnesses have been reported. However, people with an allergy or sensitivity to shellfish risk serious or life-threatening reaction if they consume a product with shellfish.

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection
This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP.

Registration Opens for FDA?s Second Annual Science Writers Symposium Formal


Registration Opens for FDA?s Second Annual Science Writers Symposium
Formal registration has begun for the U.S. Food and Drug Administration?s Second Annual Science Writers Symposium on Nov. 4-5, 2009.

FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use The


FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use
The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix to include children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR


FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR
The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President?s Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.

FDA Announces Plans for LASIK Quality of Life Project The


FDA Announces Plans for LASIK Quality of Life Project
The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

FDA: Procter & Gamble Warning Posted in Error Yesterday, a


FDA: Procter & Gamble Warning Posted in Error
Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to the FDA Web site in error.

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)

Niles, Ill. Firm Issues Allergy Alert on Classic Candy NILES,


Niles, Ill. Firm Issues Allergy Alert on Classic Candy
NILES, Ill. Affy Tapple, LLC, a Niles, Ill. firm, is voluntarily recalling its Limited Edition Classic Candy Flavors two-pack caramel apples because the label did not include the allergen statement manufactured on shared equipment with peanuts and tree nuts . Consumers who have an allergy to peanuts may run the risk of a serious allergic reaction if they consume product containing such ingredients.

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection
This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP.

Fisher/Rex Sandwiches Recalls Sandwiches Because of Possible Health Risk
Fisher/Rex Sandwiches of Raleigh, NC is recalling some of their sandwiches because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased


FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet
The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.

FDA Approves New Indication for Gardasil to Prevent Genital Warts


FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

FDA Approves New Indication for Gardasil to Prevent Genital Warts


FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

BRYAN Cervical Disc The BRYAN Cervical Disc is a titanium


BRYAN Cervical Disc
The BRYAN Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009)

Plum Organics Voluntarily Recalls Select Batch of Apple & Carrot


Plum Organics Voluntarily Recalls Select Batch of Apple & Carrot Portable Pouches Due to Potential Health Risk
Plum Organics ? announced today that it is taking the precautionary measure of voluntarily recalling one particular batch of its 4.22 oz. Apple & Carrot Portable Pouch baby food with the best by date May 21, 2010 and marked with the following universal product code (UPC) #890180001221 located on the bottom of the package. These pouches are sold individually at Toys-R-Us and Babies-R-Us locations nationally.

Fisher/Rex Sandwiches Recalls Sandwiches Because of Possible Health Risk
Fisher/Rex Sandwiches of Raleigh, NC is recalling some of their sandwiches because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

FDA, FTC Issue Joint Warning Letter to Web Site Offering


FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements
On October 15, 2009, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus.

Registration Opens for FDA?s Second Annual Science Writers Symposium Formal


Registration Opens for FDA?s Second Annual Science Writers Symposium
Formal registration has begun for the U.S. Food and Drug Administration?s Second Annual Science Writers Symposium on Nov. 4-5, 2009.

U.S. Attorney News Release: Pine Bluff Doctor Indicted on Misbranding,


U.S. Attorney News Release: Pine Bluff Doctor Indicted on Misbranding, Health Care Fraud, & Money Laundering Charges
Jane W. Duke, United States Attorney for the Eastern District of Arkansas and Steve Holt, Special Agent in Charge, U.S. Food and Drug Administration, Kansas City Field Office announced that Kelly Dean Shrum, age 41, a Doctor of Osteopathic Medicine who practiced in Pine Bluff, Arkansas, was indicted today by a federal grand jury. The indictment charges one count of Misbranding in violation of the Food, Drug, & Cosmetic Act, one count of Health Care Fraud, and three counts of Money Laundering, along with several forfeiture allegations.
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