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FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement


FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

FDA Warns Consumers Not to Use Body Building Products Marketed


FDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like Substances
The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

XACT Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens The


XACT Soft Acrylic UV Light-Absorbing Posterior Chamber Intraocular Lens
The AVS, Inc. XACT Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is plastic lens used to replace the natural lens after it is removed during cataract surgery to restore vision. (Approved: 2/2/2009)

Nutracoastal Trading LLC conducts voluntary nationwide recall of STEAM Dietary


Nutracoastal Trading LLC conducts voluntary nationwide recall of STEAM Dietary supplement lot 80214
Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA for Lot 80214 found that the product contains sulfoaildenafil, an analog of sildenafil...

Haifa Smoked Fish, Inc is voluntarily recalling Haifa Smoked Fish brand Cold Smoked Whitefish sold between December 7, 2008 and June 18, 2009 Because of Possible Health Risk
Haifa Smoked Fish, Inc is voluntarily recalling all Haifa Smoked Fish brand Cold Smoked Whitefish sold between December 7, 2008 and June 18, 2009. The product is being recalled because it has the potential to be contaminated with Listeria monocytogenes.

Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B
Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

FDA: New Public Health Regulation to Improve Egg Safety and


FDA: New Public Health Regulation to Improve Egg Safety and Reduce Salmonella Illnesses
The U.S. Food and Drug Administration today announced a regulation expected to prevent each year 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella enteritidis.

FDA Takes Enforcement Action Against Cheese Manufacturer The U.S. Department


FDA Takes Enforcement Action Against Cheese Manufacturer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, today filed a complaint seeking injunctive relief against Peregrina Cheese, Inc., (Peregrina Cheese), Brooklyn, N.Y. and two of its officers: Javier Peregrina and Isabel Peregrina.

FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair The


FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair
The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

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)

Nature & Health Co. Issues Voluntary Nationwide Recall of Six


Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements
Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs.

'G Collection' Mother's Day and Valentine's Day Gift Boxes Are Voluntarily Recalled
The G Collection Mother s Day and Valentine s Day gift boxes that were available for purchase during limited holiday timeframes in 2009 are being recalled by Godiva Chocolatier, the distributor of the G Collection.This recall is being issued because one chocolate piece in the G Collection - the Praline Crunch contains a dry nonfat milk ingredient purchased from Plainview Milk Products Cooperative, which has reported potential salmonella contamination on its equipment.

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover
Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair The


FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair
The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

FDA Urges Consumers Not to Purchase or Use Certain Gel-Filled


FDA Urges Consumers Not to Purchase or Use Certain Gel-Filled Teethers
Luv N Care Ltd. of Monroe, La., is initiating a nationwide recall of gel-filled teethers with the brand names Nuby, Cottontails and Playschool, because the liquid inside the gel-filled teethers has been found to contain Bacillus subtilis and Bacillus circulans bacteria in the gel.

FDA Approves Multaq to Treat Heart Rhythm Disorder The U.S.


FDA Approves Multaq to Treat Heart Rhythm Disorder
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

FDA Requires Labeling Change for Some Drugs Used to Prevent


FDA Requires Labeling Change for Some Drugs Used to Prevent Rejection of Kidney Transplants
The U.S. Food and Drug Administration today said that it will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections.

FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair The


FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair
The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

TECNIS Multifocal Foldable Silicone and Acrylic Intraocular Lenses The TECNIS


TECNIS Multifocal Foldable Silicone and Acrylic Intraocular Lenses
The TECNIS Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 1/16/2009)

Wirth's Nutcracker Sweet Initiates Voluntary Recall Of Pistachios Sold In


Wirth's Nutcracker Sweet Initiates Voluntary Recall Of Pistachios Sold In Michigan Because Of Possible Risk To Health
Wirth s Nutcracker Sweet of Sanford, MI is voluntarily recalling 258 of their 2-lb holiday party trays containing roasted and salted pistachios in the shell because they have the potential to be contaminated with salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover
Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

FDA Warns Consumers Not to Buy or Use Hardcore Energize


FDA Warns Consumers Not to Buy or Use Hardcore Energize Bullet or New Whey Liquid Products
The U.S. Food and Drug Administration is warning consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials due to suspected product tampering. The products are being recalled.

U.S. Attorney News Release: Michigan Business Owner Pleads Guilty to


U.S. Attorney News Release: Michigan Business Owner Pleads Guilty to Fraudulently Marketing Dietary Supplements
Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Michigan business owner pleaded guilty in federal court today to his role in a conspiracy to fraudulently market dietary supplements over the Internet with illegal claims that these supplements could prevent, treat or cure a number of diseases. Several Web sites were used to sell nearly $12 million worth of the products in 2005 and 2006.

FDA Approves Effient to Reduce the Risk of Heart Attack


FDA Approves Effient to Reduce the Risk of Heart Attack in Angioplasty Patients
The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.

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)
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