FDA News
News from The FDA
Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available.
Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA).
Trasylol (aprotinin injection)Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
Heparin Sodium InjectionFDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use.
Cardinal Alcohol-Free MouthwashProduct recalled because of the presence of Burkholderia cepacia.
May 2008 Patient Safety NewsVideo news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
Enbrel (etanercept)Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis.
Total Body Formula, Total Body Mega FormulaFDA analysis reveals high chromium levels in addition to selenium.
Heparin Sodium InjectionUpdate to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.
Digitek (digoxin tablets, USP)Class I recall because tablets may contain twice the approved level of active ingredient.
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FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)
The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.
Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12)Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate.
Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15)Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN.
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.
Updated Press Release: Lezza Blue Raspberry Italian Ice RecalledThe product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007.
Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.
Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2)Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines
(April 28)Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium.
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein.
DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).
Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11)Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites.
Fine Land Corp Issues Alert on Undeclared Sulfites in Golden Girl Brand "Mut Gung" Sweetened Ginger (April 8)Fine Land Corp, 239 Bay 20th Street, Brooklyn, NY 11214 is recalling its Golden Girl brand "Mut Gung" sweetened ginger because it contains undeclared sulfites.
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FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.
FDA Shuts Down Seafood Processing Company, Requires Products Be RecalledThe U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.
FDA Takes Action against Cream Cheese Companies, ExecutivesThe U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws.
Manufacturer Removes Remaining Stocks of TrasylolBayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician?s stock. The FDA will work with Bayer to ensure a smooth and complete process.
FDA Approves New Formulation of Coagulation Therapyhe U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
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