June 2009 - FDA News

U.S. Attorney News Release: Business Owners Plead Guilty to Distributing

U.S. Attorney News Release: Business Owners Plead Guilty to Distributing Tainted Ingredient Used in Pet Food
KANSAS CITY, Mo. Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007.

FDA Issues Public Health Advisory Regarding Levemir Insulin The U.S.

FDA Issues Public Health Advisory Regarding Levemir Insulin
The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

Reclaim? DBS? Therapy for OCD What is it? A totally

Reclaim? DBS? Therapy for OCD
What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Approved: 2/19/2009)

Provide Commerce, Inc. Initiates Nationwide Voluntary Recall of Items Containing

Provide Commerce, Inc. Initiates Nationwide Voluntary Recall of Items Containing Peanuts Due to Recall by Peanut Corporation of America
As a precautionary measure, Provide Commerce, Inc. of San Diego, CA has initiated a nationwide voluntary recall of certain items distributed under Provide Commerce s brand names of ProFlowers, Cherry Moon Farms, Secret Spoon, RedEnvelope and Shari s Berries.

Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products
June 15, 2009 - Norcross, GA - Hi-Tech Pharmaceuticals, Inc. ( Hi-Tech ), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company's product sold under the name Stamina-Rx.

FDA Requests Labeling Change for Leukotriene Modifiers The U.S. Food

FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for

U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud
A federal grand jury yesterday indicted Pamela Arrey, age 48, Glenelg, Maryland, for health care fraud and aggravated identity theft, announced United States Attorney for District of Maryland Rod R. Rosenstein

FDA Approves Injectable Form of Ibuprofen The U.S. Food and

FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

FDA Requests Labeling Change for Leukotriene Modifiers The U.S. Food

FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).

FDA Issues Safety Communication about an Ongoing Review of Stimulant

FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
There may be an association between the use of stimulant medications for attention- deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study s limitations, parents should not stop a child s stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional.

ARCHITECT CORE Reagent Kit, Calibrator and Controls The ARCHITECT

ARCHITECT CORE Reagent Kit, Calibrator and Controls
The ARCHITECT CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. (Approved: 4/10/2009)

Sconza Candy Company Voluntarily Initiates Nationwide Recall of Trail Mix,

Sconza Candy Company Voluntarily Initiates Nationwide Recall of Trail Mix, Organic Chocolate Peanuts and Organic Toffee Cashews and Peanuts Because of Possible Health Risk SECOND RELEASE.
Sconza Candy Company Voluntarily Initiates Nationwide Recall of Trail Mix, Organic Chocolate Peanuts and Organic Toffee Cashews and Peanuts Because of Possible Health Risk SECOND RELEASE.

Smith Dairy Announces Voluntary Recall on SMITH'S Tea with Lemon in Gallon Size Only
Smith Dairy Products Company today announced a voluntary recall on SMITH S Tea with Lemon in gallon size, lot no. 07/07/09

U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for

U.S. Attorney News Release: Howard County Pharmacy Owner Indicted for Health Care Fraud
A federal grand jury yesterday indicted Pamela Arrey, age 48, Glenelg, Maryland, for health care fraud and aggravated identity theft, announced United States Attorney for District of Maryland Rod R. Rosenstein

FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus

FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus.

FDA Issues Public Health Advisory Regarding Levemir Insulin (Spanish) La

FDA Issues Public Health Advisory Regarding Levemir Insulin (Spanish)
La Administraci n de Medicamentos y Alimentos de los Estados Unidos se ha enterado que algunas ampollas de insulina Levemir de acci n prolongada, medicamento elaborado por Novo Nordisk Inc., que hab an sido robadas, han aparecido y se encuentran a la venta en los Estados Unidos. El total de ampollas robadas es de 129,000 unidades, lo que equivale a tres lotes del producto. Cabe la posibilidad de que estas ampollas de insulina robadas no hayan sido almacenadas ni manipuladas adecuadamente, lo que puede ser peligroso para los pacientes que la usan.

REPEL-CV Bioresorbable Adhesion Barrier REPEL-CV Bioresorbable Adhesion Barrier is a

REPEL-CV Bioresorbable Adhesion Barrier
REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Approved: 3/6/2009)

Smith Dairy Announces Voluntary Recall on SMITH'S Tea with Lemon

Smith Dairy Announces Voluntary Recall on SMITH'S Tea with Lemon in Gallon Size Only
Smith Dairy Products Company today announced a voluntary recall on SMITH S Tea with Lemon in gallon size, lot no. 07/07/09

Sconza Candy Company Voluntarily Initiates Nationwide Recall of Trail Mix, Organic Chocolate Peanuts and Organic Toffee Cashews and Peanuts Because of Possible Health Risk SECOND RELEASE.
Sconza Candy Company Voluntarily Initiates Nationwide Recall of Trail Mix, Organic Chocolate Peanuts and Organic Toffee Cashews and Peanuts Because of Possible Health Risk SECOND RELEASE.

NY Fish Inc. Recalls Imperial-European Style Smoked Salmon Because of Possible Health Risk
N.Y. Fish, Inc. of Brooklyn, NY is recalling I NY Fish brand Imperial-European Style Smoked Salmon in vacuum packed 3 oz, 8 oz, 16 oz, and whole side to be weighed at time of sale sizes of lots starting with # 142 xxxx, because it has 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.

FDA Taking Steps to Improve Contact Lens Safety The U.S.

FDA Taking Steps to Improve Contact Lens Safety
The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness.

U.S. Attorney News Release: Pharmaceutical Company Manager Sentenced for Off-Label

U.S. Attorney News Release: Pharmaceutical Company Manager Sentenced for Off-Label Marketing
BOSTON, MA - A Branchburg, NJ, woman was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

FDA Warns Consumers Not to Use Skin Products Made by

FDA Warns Consumers Not to Use Skin Products Made by Clarcon Due to Bacterial Contamination Risk
The U.S. Food and Drug Administration announced today that Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products.