FDA News

News from The FDA

Tumor necrosis factor-a blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)

Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-a blockers.

September 2008 Patient Safety News

Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Pacific Consolidated brand Mobile Oxygen Storage Tank

Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.

Tysabri (natalizumab)

Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year.

Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)

Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer.

Byetta (exenatide)

UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta.

July 2008 Monthly Safety Labeling

Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure.

Vivitrol (naltrexone)

Serious injection site reactions may occur with the use of injectable naltrexone.

Fentanyl Transdermal System CII Patches

UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel.

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

UPDATE - Dear Healthcare Professional letter added.

...More Med Watch news from the FDA

Food and Drug Administration--Recalls

Recall of Patak's Dopiaza Cooking Sauce (September 4)

ACH Food Companies, Inc. is recalling its Patak's Dopiaza Cooking Sauce sold in the United States because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products. The product is distributed nationally through retail stores. ACH Food Companies is notifying its distributors and stores that carry this product that it contains an undeclared milk allergen and to immediately remove it from distribution.

Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5)

Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts.

T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4)

T. Marzetti Company is recalling a limited number of 12 fl. oz. bottles of Girard's Honey Dijon Peppercorn (item 58105) because they may have the incorrect back label of Girard's French Dressing (item 58015). The Girard's Honey Dijon Peppercorn contains eggs, which is not declared as an ingredient on the Girard's French label. People who have allergies to egg run the risk of serious allergic reaction if they consume this product.

The Hershey Company Announces Nationwide Voluntary Recall of Hershey's Chocolate Shell Topping Due to Undeclared Almonds (September 4)

The only 7.25-ounce bottles of Hershey's Chocolate Shell Topping affected have the code 69N printed on the back of the bottle below the UPC symbol. The UPC/Bar Code is 346000. The item in question was available for purchase nationwide after July 8, 2008.

Starway Inc. Issues Alert on Undeclared Sulfites in Ego Brand Preserved Peaches (September 3)

EGO brand Preserved Peaches is sold in a 14 ounce, un-coded, clear plastic package and was distributed nationwide. It is a product of Malaysia.

Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29)

Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 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.

Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28)

Landshire, Inc. is recalling its American Sub sandwich 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.

QFC Recalling Deli Tuna Salad Items in Washington and Oregon (August 28)

Quality Food Centers (QFC) said today it is recalling five deli tuna salad items sold at some QFC stores in Washington and Oregon.

Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13)

The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label.

Manufacturer for Publix Brand Vanilla Wafers Issues a Recall for Undeclared Soy (August 15)

The manufacturer of Publix Vanilla Wafers is recalling a limited number of 12oz boxes of Vanilla Wafers with a code date of 030409A as they may contain undeclared soy. Persons who have an allergy to soy run the risk of a serious or possible life-threatening allergic reaction if they consume the affected product. The UPC number may be found on the side label below the Nutrition Facts panel: Publix Vanilla Wafers, UPC: 41415-00609

FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15)

The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps.

Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14)

Peppers Unlimited, Inc. of Fontana California is voluntarily recalling 580 cases of La Torre Jalapeno Nacho Slices because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor.

Whole Foods Market Issues Recall on 365 Organic Everyday Value Popcorn, Lightly Salted Due to Undeclared Dairy Allergen (August 14)

This product was distributed to and sold in Whole Foods Market retail stores in California, Arizona, Nevada, Kentucky, Maryland, Ohio, Pennsylvania, Virginia, Washington D.C, Connecticut, Maine, Massachusetts, Rhode Island, Oregon, New Jersey, New York and Washington.

Mars Petcare US Issues Voluntary Recall of Limited Bags of PEDIGREE Complete Nutrition Small Crunchy Bites at Albertsons in Southern California and Las Vegas due to Potential Salmonella Contamination (August 8)

Mars Petcare US today announced a voluntary recall of limited bags of PEDIGREE® Complete Nutrition Small Crunchy Bites sold in Albertsons stores in Southern California and Las Vegas, Nevada. The pet food is being voluntarily recalled because of potential contamination with Salmonella. There have been no complaints or reports of injury resulting from consumption or handling of the recalled product.

S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12)

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites

Hop Lee Trading Co., Inc. Issues Alert on Undeclared Sulfites in Flower Brand Dried Sweet Potato (August 12)

Hop Lee Trading Co. Inc. is recalling Flower brand Dried Sweet Potato because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11)

Home Made Brand Foods is voluntarily recalling approximately 4890 pounds of Ready-to-Eat Tuna Salad with an expiration date of 8/19/08. This product 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 Warns Consumers About Potential Problems at Two Baltimore Pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4)

CF Sauer Foods Inc, of Richmond, VA is recalling all packages of Gold Medal Spaghetti Sauce Mix with the code date as follows: 8119R. People who have an allergy or severe sensitivity to milkrun the risk of serious or life threatening allergic reaction if they consume these products.

Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31)

The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products.

FDA Extends Consumer Warning on Serrano Peppers from Mexico

Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.

EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient

EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil.

Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25)

The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE.

...More recall information from the FDA

Food and Drug Administration Press Releases

FDA to Post Quarterly Report of Potential Safety Issues

The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

FDA Approves DNA Test to Measure Hepatitis B Virus Levels

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

FDA Clears Test to Help Doctors Manage Heart Transplant Patients

The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

...More Press Releases information from the FDA

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