Class I Medical Device Recall: Nebion, LLC HLX-8 Magnetic Resonance Device
Closed Published by CDRH Consumer News October 2nd, 2008 in Regulatory AffairsReason for Recall: This device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.
Consumer Information on: Invitrogen SPOT-Light® HER2 CISH™ Kit - P050040
Closed Published by CDRH Consumer News July 31st, 2008 in Regulatory AffairsThe SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method.
Class I Medical Device Recall: Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board)
Closed Published by CDRH Consumer News July 31st, 2008 in Regulatory AffairsReason for Recall: Use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death.
Consumer Information on: EVOLENCE® Collagen Filler - P070013
Closed Published by CDRH Consumer News July 24th, 2008 in Regulatory AffairsEvolence® Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the…
NeurogesX Initiates Dosing In Phase 1 Clinical Trial For NGX-1998 Capsaicin Liquid Formulation
Closed Published by Food and Drug Administration News July 13th, 2008 in UncategorizedMain Category: Pain / Anesthetics Also Included In: Clinical Trials / Drug Trials ; Pharma Industry / Biotech Industry Article Date: 12 Jul 2008 - 0:00 PDT NeurogesX, Inc.
Consumer Information on: Medtronic® Attain StarFix™ Model 4195 Lead - P060039
Closed Published by CDRH Consumer News July 10th, 2008 in Regulatory AffairsThe Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over..
Consumer Information on: XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems - P070015
Closed Published by CDRH Consumer News July 2nd, 2008 in Regulatory AffairsThe XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood…
Consumer Information on: Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System - P070016
Closed Published by CDRH Consumer News July 2nd, 2008 in Regulatory AffairsThe Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall.
Glaxo’s Cervarix vaccine faces further delay
Closed Published by Food and Drug Administration News June 30th, 2008 in UncategorizedGlaxoSmithKline Plc does not expect to win U.S. approval for its key cervical cancer vaccine Cervarix until late 2009, marking a further delay for the product.
/R E P E a T — Oncolytics Biotech Inc. Announces U.S. Phase 2…
Closed Published by Food and Drug Administration News June 22nd, 2008 in UncategorizedOncolytics Biotech Inc. announced today that following U.S. Food and Drug Administration review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN in …
US FDA seeks India post for food, drug checks - Reuters India
Closed Published by Google Inc. June 21st, 2008 in Google FDA News, Regulatory AffairsUS FDA seeks India post for food, drug checks Reuters India, India - By Lisa Richwine and Susan Heavey WASHINGTON (Reuters) - The US Food and Drug Administration hopes to establish operations in India by year's end to better ... |
Warning issued about stop-smoking drug - Globe and Mail
Closed Published by Google Inc. June 21st, 2008 in Google FDA News, Regulatory AffairsWarning issued about stop-smoking drug Globe and Mail, Canada - The US Food and Drug Administration made a similar announcement in February.And last month, US officials banned pilots and air-traffic controllers from ... |
Commentary: Toward a Fuller Understanding of Business Risks in China - US-China Today
Closed Published by Google Inc. June 20th, 2008 in Google FDA News, Regulatory AffairsCommentary: Toward a Fuller Understanding of Business Risks in China
US-China Today, CA - Within the last few weeks, US Food and Drug Administration (FDA) investigators have stated that the contamination appears to be an intentional criminal act … New Foreign Drug Trial Rule Coming |
Ligand says FDA extends blood-clot drug review - Forbes
Closed Published by Google Inc. June 20th, 2008 in Google FDA News, Regulatory AffairsLigand says FDA extends blood-clot drug review
Forbes, NY - AP 06.20.08, 4:31 PM ET Drug developer Ligand Pharmaceuticals Inc. said after the bell Friday the Food and Drug Administration will take an additional three … Ligand Partner GlaxoSmithKline Receives FDA Extended Priority … GSK Update on FDA Review of Promacta(R) (Eltrombopag) GlaxoSmithKline: FDA extends priority review period for Promacta |
UPDATE 1-Merck may wait to 2013 in US for cholesterol drug - Reuters
Closed Published by Google Inc. June 20th, 2008 in Google FDA News, Regulatory AffairsUPDATE 1-Merck may wait to 2013 in US for cholesterol drug
Reuters - N: Quote, Profile, Research) said on Friday it may have to wait until 2013 before the US Food and Drug Administration will consider its experimental … Is Merck Flying Blind? UPDATE: Long Delay Seen For Merck's Cholesterol Drug Health Winners & Losers: Biovail |
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This site is a resource for Regulatory Affairs Professionals. It syndicates news feeds from various resources to help keep you informed of breaking news. Please navigate this site using the above search box, article attribution links, or any other links of interest.
Site Update - the site software has been updated for improved security and to provide more features, including the Content Cloud and Recent Recall abstracts (see below). Also, NIH News has been added as a content contributor.
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Recent Recalls lists the ten (10) most recent FDA recall announcements (note: the "#" symbol links to the original post).
Recent Recalls
» Bay Valley Foods is recalling 535 cases of America’s Choice Classic Caesar Dressing because some of the bottles produced in February 2008 have an incorrect ingredient label on the back of the bottle. The incorrect label on the back includes ingredient and nutrition information for Chunky Blue Cheese Dressing and does not declare the presence of fish, soy and wheat. Consumers who have allergies to fish, soy and wheat run the risk of a serious or life threating allergic reaction if they consume the mislabeled product.
» JARD Marketing, Lawrence, Massachusetts is recalling selected fresh cut fruit products which contain cantaloupe which has the potential to be contaminated with Salmonella. On March 26, 2008, JARD marketing was requested by its supplier T. M. Kovacevich International Inc, to recall products produced with cantaloupe from Agropecuaria Montelibano.
» Organic yogurt maker Stonyfield Farm has announced a voluntary product recall of its non-fat blueberry yogurt products. The recall comes in response to the possibility of glass fragments in the product.
» Dole Fresh Fruit Company, a subsidiary of Dole Food Company, Inc., has voluntarily recalled all Honduran Cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras.
» Spokane Produce, Inc. of Spokane, Washington is recalling Garden Patch, Yokes, and Rosauers Classic labels of various products of fresh cut and cut fruits containing cantaloupe, 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.
» Chiquita Brands International, Inc. today announced a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano in Honduras. The product was distributed to customers nationwide and is being recalled because they have the potential to be contaminated with Salmonella.
» The recalled product was distributed nationwide to wholesalers and grocery stores. Whole cantaloupe fruits subject to this recall are packed three melons in a sleeve under the brand “Chestnut Hill Farms” and one melon per sleeve under the “Perfect Melon” brand. Individual melons are not labeled, but sleeves contain tags that say either “Perfect Melon” (one count) or “Chestnut Hill Farms” (3 count). Whole cantaloupe fruits subject to this recall were sold in boxes marked with the following text: “Cantaloupe, “Chestnut Hill Farms” (3 count) or “Perfect Melon” (one count), Produce of Honduras, Grown, Packed and Shipped by Agropecuaria Montelibano, San Lorenzo, Valle, Honduras”. All boxes also contain the Chestnut Hill Farms logo.
» T.M. Kovacevich International, Inc. of Philadelphia, PA is recalling cantaloupes which it purchased from Agropecuaria Montelibano, a Honduran grower and packer, because the U.S. Food and Drug Administration (’FDA’) has determined, based on current information, that cantaloupe fruit from this company has 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.
» Simply Fresh Fruit, of Los Angeles, California is recalling selected fresh cut fruit products which may contain cantaloupe which has the potential to be contaminated with Salmonella.
» Tropifresh, Inc. of Los Angeles, CA is recalling Agrolibano’s Produce Brand whole Cantaloupes because they appear 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.
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