http://www.biospace.comBioSpace RSS GeneratorFri, 24 May 2013 01:26:37 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.pharmalive.com/those-jj-recalls-keep-on-coming-tylenol-is-yanked-from-brazilStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Despite assorted efforts to get its corporate house in order, Johnson & Johnson simply cannot escape manufacturing problems. The latest escapade has occurred in Brazil, where more than 3.3 million bottles of...Thu, 23 May 2013 12:00:00 AM GMThttp://www.in-pharmatechnologist.com/Regulatory-Safety/Sandoz-Recalls-Injectable-Following-Contamination-at-Austrian-PlantStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Sandoz is conducting a voluntary nationwide recall at the US hospital/user level of 2 lots of its injectable methotrexate sodium, USP, 25 mg/mL, 40 mL vials, as a result of the discovery of particulate matter...Thu, 23 May 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/05/22/us-amag-anemiadrug-idUSBRE94K19Q20130522Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Amag Pharmaceuticals Inc said its marketing partner in Switzerland, Takeda Pharmaceutical Co Ltd, is recalling a batch of Amag's anemia drug, Rienso, because of a death and several cases of hypersensitivity...Wed, 22 May 2013 12:00:00 AM GMThttp://www.outsourcing-pharma.com/Contract-Manufacturing/Possible-API-Contamination-at-Chinese-CMO-Leads-to-Canadian-RecallsStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.<br><br>Help employers find you! Check out all the <a href...Wed, 22 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=297216&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><font size"3"><b>Health Canada: Three Companies Voluntarily Recalling All Lots of Their Antipsychotic Medication Due to Possible Contamination Issues</font></b><br><br>OTTAWA, ONTARIO, May 18, 2013 (Marketwired...Mon, 20 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=296378&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><b>Additional Lots Added: Voluntary Nationwide Recall of 21 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution...Mon, 13 May 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/05/06/migrainedrug-fda-idUSL3N0DN2LA20130506Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>May 6, 2013 -- The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose...Tue, 07 May 2013 12:00:00 AM GMThttp://www.indianexpress.com/news/johnson---johnsons-license-revoked-on-baby-powder-concerns/1111411/Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Health officials have revoked Johnson & Johnson's license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder...Mon, 06 May 2013 12:00:00 AM GMThttp://www.pharmalive.com/jj-is-forced-to-halt-tylenol-production-in-korea-over-mishapStaying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Johnson & Johnson may have a new image campaign to help consumers, investors and physicians overlook the cascade of recalls and scandals (see this), but such promotional efforts are no substitute for improved...Mon, 06 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=294649&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>WESTON, FL, April 26, 2013 /PRNewswire/ - Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam...Tue, 30 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=294840&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>RIDGEFIELD, Conn.</span>, <span class"xn-chron">April 30, 2013</span> /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced three important updates to the U.S. prescribing information...Tue, 30 Apr 2013 12:00:00 AM GMThttp://www.pharmafile.com/news/178974/takeda-rapped-over-quality-control-failure-japanTakeda Pharmaceutical has been penalised by its local trade organisation over the quality failings that led to the recall of an injectable dietary supplement product. The Osaka Pharmaceutical Manufacturers Association (OPMA) has suspended Takeda's activities as chair of the good manufacturing practice (GMP) committee, and vice-chair of the pharmaceutical laws and regulations committee for six months...Mon, 22 Apr 2013 12:00:00 AM GMThttp://www.theatlanticwire.com/technology/2013/04/fda-let-drugs-approved-fraudulent-research-stay-market/64231/On the morning of May 3, 2010, three agents of the Food and Drug Administration descended upon the Houston office of Cetero Research, a firm that conducted research for drug companies worldwide. Lead agent Patrick Stone, now retired from the FDA, had visited the Houston lab many times over the previous decade for routine inspections. This time was different. His team was there to investigate a former...Tue, 16 Apr 2013 12:00:00 AM GMThttp://www.bloomberg.com/news/2013-04-12/glaxo-s-avandia-gets-second-look-at-heart-risk-by-u-s-.htmlGlaxoSmithKline Plc (GSK)s Avandia, the best-selling diabetes pill that was pulled off the market in Europe and tightly restricted in the U.S. because of its heart risks, will undergo another regulatory review. The U.S. Food and Drug Administration plans a June meeting to discuss a re-analysis of a 2009 study, known as Record, that found Avandia more than doubled the risk of heart failure, without...Fri, 12 Apr 2013 12:00:00 AM GMThttp://www.pharmalive.com/waiter-theres-cardboard-my-sample-fda-warns-pfizer-over-manufacturing-gaffesIn its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of batches of a diluting agent for its Torisel kidney cancer drug and claiming false positives were caused by interference from cardboard packaging. Yes, cardboard. The drugmaker, however, failed to offer any...Fri, 12 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=292382&full=1Pfizer Inc. has recalled about 52,000 bottles of thyroid-disease treatment Levoxyl because of complaints of uncharacteristic odors in some bottles.</p><p>Pfizer stopped shipping the drug in February after learning of the odor problem, and may not have new supply available until 2014 because any changes to the product may take time to evaluate, spokeswoman Lauren Starr said. The product has been...Fri, 05 Apr 2013 12:00:00 AM GMThttp://www.wpri.com/dpp/news/fda-warns-ri-pharmaceutical-companyAlexion Pharmaceuticals said Thursday it received a warning letter from the U.S. Food and Drug Administration over the companys own investigation of bacterial contamination at a Rhode Island facility. In a press statement, Alexion said the letter follows inspections of the facility in August where Alexion produces Soliris, a treatment for a blood disorder known as paroxysmal noctural hemoglobinuria...Tue, 02 Apr 2013 12:00:00 AM GMThttps://www.massdevice.com/news/hospira-recalls-contaminated-saline-solutionBrass particulates discovered in 1 lot of Hospira's hydration injection container prompt a recall. Hospira (NYSE:HSP) pulled a batch of sodium chloride injection containers over concerns about contamination with metal particles. There was 1 confirmed report that the flexible container contained several grey/brown particles, which were later identified as copper, zinc and lead. Hospira is warning customers...Tue, 02 Apr 2013 12:00:00 AM GMThttp://www.pharmalot.com/2013/03/apotex-is-in-the-fda-dog-house-again/In the latest row between the FDA and Apotex over its manufacturing practices, the agency has issued another warning letter that takes the generic drugmaker to task for a host of serious violations at two separate plants in Canada. The missive also notes that agency inspectors encountered repeat infractions and a persistent failure to make the necessary corrections. There is a sad history here. Four...Thu, 21 Mar 2013 12:00:00 AM GMThttp://www.washingtonpost.com/politics/fda-flags-georgia-compounding-pharmacy-recall-of-avastin-eye-injections-linked-to-infection/2013/03/20/af71729e-9176-11e2-9173-7f87cda73b49_story.htmlSterility problems persist at compounding pharmacies six months after the fungal meningitis outbreak, with yet another safety alert issued this week. The latest contamination is the result of a cost-saving measure similar to one that resulted in the death of an East Nashville man last summer. After five people suffered eye infections, Clinical Specialties of Augusta, Ga., on Monday recalled shipments...Thu, 21 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290744&full=1Dr Reddys Laboratories has recalled its anti-depression drug Citalopram from the US market, following complaints of a strong odour. Mumbai-based Glenmark Pharmaceuticals too recalled its allergy and asthma drug in February, after reports that some batches of bottle containing the Montelukast sodium tablets were emitting an odour. Dr Reddys generates more than 50 per cent of its revenues from the...Tue, 19 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290628&full=1[3-14-2013] The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination...Mon, 18 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290609&full=1SAN DIEGO</span> and <span class"xn-location">HUNTERSVILLE, N.C.</span>, <span class"xn-chron">March 14, 2013</span> /PRNewswire/ -- <a href"http://www.robbinsarroyo.com/about-us/" target"_blank">Shareholder rights</a> firm Robbins Arroyo LLP is investigating whether officers and directors of Impax Laboratories, Inc. (NASDAQ: IPXL) breached their fiduciary duties to shareholders by failing to correct...Mon, 18 Mar 2013 12:00:00 AM GMThttp://www.usatoday.com/story/news/nation/2013/03/12/fda-zithromax-warning/1982805/Doctors should be aware of potential risks to patients with heart conditions when prescribing the antibiotic azithromycin, U.S. regulators said. The Food and Drug Administration today updated the labeling information on the drug to reflect increased risk of fatal irregular heartbeats in patients. Research published last year found that the pills, used to treat infections, caused a small increase in...Wed, 13 Mar 2013 12:00:00 AM GMThttp://www.bloomberg.com/news/2013-03-01/salmon-hormone-may-contain-too-much-cancer-risk.htmlA salmon hormone used to treat post- menopausal osteoporosis may not reduce bone fractures enough to outweigh the drugs cancer risks, U.S. regulators said. Three studies on oral, injectable and nasal calcitonin- salmon formulations sold by Novartis AG (NOVN), Upsher-Smith Laboratories Inc. and other companies showed unreliable or disappointing results, Food and Drug Administration staff said today...Tue, 05 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288471&full=1PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (AFFY) and Takeda Pharmaceutical Company Limited (Takeda) today have decided to voluntarily recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been...Wed, 27 Feb 2013 12:00:00 AM GMThttp://www.pharmalot.com/2013/02/ranbaxy-slams-consumers-for-seeking-lipitor-recall/Last November, Ranbaxy Laboratories recalled more than three dozen lots of generic Lipitor because some contained tiny glass particles and the generic drugmaker then halted all production of the cholesterol pill. Not surprisingly, the move prompted lawsuits, even though the FDA indicated the likelihood of patient harm appeared to be extremely low. But several consumers are asking a federal judge...Mon, 25 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288124&full=1<div id"releaseBody"><p>ST. LOUIS, MO--(Marketwire - February 20, 2013) - Mobius Therapeutics, the makers of <b>Mitosol&#174; (mitomycin for solution) Kit for Ophthalmic Use</b>, announced today that the source for the recent voluntary recall of two lots was likely due to laboratory contamination induced at the time of testing.<p>"Upon investigation, we have determined conclusively that, during...Wed, 20 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=287929&full=1FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) today announced it is voluntarily recalling lot B120217A of Vistide (cidofovir injection) to the user level due to the presence of particulate matter found in some vials of this lot.</p><p>Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into...Tue, 19 Feb 2013 12:00:00 AM GMThttp://www.washingtonpost.com/business/fda-says-weight-loss-supplements-from-florida-company-contain-risky-drug-ingredient/2013/02/14/27a6655c-76f7-11e2-b102-948929030e64_story.htmlU.S. Marshals, acting on behalf of the U.S. Food and Drug Administration, today seized tainted dietary supplements from Globe All Wellness, LLC (Globe All), in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient. Several of the seized products contain sibutramine hydrochloride (sibutramine), the active ingredient in the obesity drug Meridia...Fri, 15 Feb 2013 12:00:00 AM GMThttp://www.oncologypractice.com/oncologyreport/news/top-news/single-view/fda-detects-a-new-counterfeit-bevacizumab/902bcd8b864e66c54a361f7a5cdcafd1.htmlThe Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung...Fri, 08 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286745&full=1<div id"releaseBody"><p>BAGSVAERD, DENMARK--(Marketwire - February 05, 2013) - <p><br>Company announcement No 10 / 2013:<a href"http://hugin.info/2013/R/1675578/545854.pdf">http://hugin.info/2013/R/1675578/545854.pdf</a><p>This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:<p>(i) the releases contained...Tue, 05 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286380&full=1MISSISSAUGA, ON, Jan. 31, 2013 /CNW/ - Novartis Consumer Health Canada Inc. announced today that it is voluntarily recalling Triaminic and Jack & Jill pediatric syrups, NeoCitran syrups and certain Buckley's Complete liquids. Novartis Consumer Health Canada Inc. has decided to issue a voluntary recall to consumers, retail customers and wholesalers because the child-resistant feature of the bottle...Fri, 01 Feb 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/01/30/france-pill-diane-idUSL5N0AZBLE20130130France's health regulator ANSM said on Wednesday it would suspend sales of Bayer acne pill Diane 35 and its generic versions, all also used as a contraceptive, after four deaths over the past 25 years were linked to its use. About 315,000 women used Diane 35 or its generic version in France last year. Bayer officials were not immediately available to comment on the suspension of the drug, which is...Thu, 31 Jan 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/01/28/us-hospira-recall-idUSBRE90R12620130128Hospira Inc is recalling one lot of an intravenous electrolyte solution after the discovery of the presence of a substance that was consistent with mold, U.S. health regulators said on Monday. The Food and Drug Administration said the affected lot of the product, known as Lactated Ringer's and 5% Dextrose Injection, was distributed nationwide between June 2011 and January 2012 to wholesalers, hospitals...Tue, 29 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285724&full=1January 25, 2013 -- AUDIENCE: Gastroenterology, Nephrology, Pharmacy</p><p>ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed...Fri, 25 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285178&full=1January 17, 2013 - Advance Pharmaceutical Inc. today announced that it is conducting a voluntary nationwide recall of one lot of Ferrous Sulfate Tablets, 325 mg, Lot 12G468 Exp. 07/14, UPC Barcode 0 0536-5890-01 3. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate. Advance Pharmaceutical Inc. initiated...Fri, 18 Jan 2013 12:00:00 AM GMThttp://www.chicagobusiness.com/article/20130111/NEWS03/130119928/abbvie-recalling-thyroid-drugAbbVie Inc., the Abbott Laboratories spinoff, has recalled more than 28,520 bottles of the thyroid-hormone replacement therapy Synthroid over a labeling error. It is the second recall of the drug in six months. Synthroid is a synthetic thyroid hormone used to treat hypothyroidism, when the thyroid gland doesn't produce enough natural thyroid hormone. One lot of 150-microgram Synthroid tablets was recalled...Wed, 16 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=284434&full=1<div id"releaseBody"><p>ST. LOUIS, MO--(Marketwire - January 10, 2013) - On 10 January 2013, Mobius Therapeutics, LLC, St. Louis, MO, announced today that it is conducting a voluntary recall of 2 lots of Mitosol&#174; (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company is taking this voluntary action due to the fact that we cannot exclude the possibility that the affected...Thu, 10 Jan 2013 12:00:00 AM GMThttp://www.bloomberg.com/news/2013-01-08/j-j-diabetes-pill-may-have-heart-risks-fda-staff-says.htmlJohnson & Johnson (JNJ)s experimental diabetes pill may carry heart risks, U.S. regulators said in a review that threatens to delay the companys first-to-market status among a new family of medicines. Studies for the drug canagliflozin, which expels sugar in the urine after its filtered from blood by the kidneys, showed a potentially higher risk for heart events in the first 30 days compared with...Thu, 10 Jan 2013 12:00:00 AM GMThttp://www.claimsjournal.com/news/national/2012/12/27/219805.htmA Canadian supplier has distributed unapproved Botox which could turn out to be "counterfeit or unsafe," according to the U.S. Food and Drug Administration. The FDA sent out warning letters in December to more than 350 medical practices alerting them of danger, the Associated Press said. The letter noted that batches of the popular wrinkle treatment drug shipped by the pharmacy Canada Drugs haven...Thu, 27 Dec 2012 12:00:00 AM GMTDecember 27, 2012 -- Mylan announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573).</p><p>The three lots, manufactured by Qualitest Pharmaceuticals, were repackaged and distributed by Mylan in unit dose (CD100) under the UDL Laboratories label. The lot numbers are Lots 3...Thu, 27 Dec 2012 12:00:00 AM GMTwww.rttnews.com/2026357/vertex-pharma-s-incivek-label-to-carry-boxed-warning.aspxDecember 19, 2012 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment. Fatal cases of serious skin reactions have been reported in patients with progressive...Wed, 26 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282924&full=1 <div class"xn-content"><p><span class"xn-location">RIDGEFIELD, Conn.</span>, <span class"xn-chron">Dec. 19, 2012</span> /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement...Thu, 20 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282711&full=1December 17, 2012 - Performance Plus Marketing, Inc. Issues a Voluntary Nationwide Recall of Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova because they contain undeclared Sulfoaildenafil and Thioaildenafil.</p><p>Performance Plus Marketing, Inc. has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis...Wed, 19 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282719&full=1SCOTTSDALE, Ariz., Dec. 18, 2012 /PRNewswire/ -- Matrixx Initiatives is voluntarily recalling 1 lot of Zicam Extreme Congestion Relief nasal gel. The company is taking this step after finding a small amount of Burkholderia cepacia in a single sample of the product taken from the affected lot. The problem was detected during a routine review at the manufacturing facility. Tests on additional samples...Wed, 19 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282459&full=1December 14, 2012 - Lake Forest, Ill - Hospira, Inc. (NYSE: HSP), issued this press release today to further inform the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira customers were notified...Mon, 17 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281692&full=1MORRISTOWN, N.J.</span>, <span class"xn-chron">Dec. 7, 2012</span> /PRNewswire/ -- In consultation with the U.S. Food and Drug Administration (FDA), Bayer HealthCare's Consumer Care division has begun a voluntary recall of BRONKAID Caplets Dual Action Formula. Bayer initiated the recall after identifying that certain information was inadvertently excluded from the product carton label. It is important...Mon, 10 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281564&full=1HUNTSVILLE, Ala.</span>, <span class"xn-chron">Dec. 6, 2012</span> /PRNewswire/ -- Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter "C". </p><div><table style"BORDER...Fri, 07 Dec 2012 12:00:00 AM GMThttp://www.voxxi.com/generic-wellbutrin-pulled-off-market/The Food and Drug Administration (FDA) has pulled bupropion, the generic form of the antidepressant drug Wellbutrin, off the market. The decision was made after analysis showed the generic form of the bupropion, 300 mg dose, was not bioequivalent to its Wellbutrin counterpart. The discovery led to Impax Laboratories and distributor Teva Pharmaceuticals having to stop distribution of the medication...Fri, 07 Dec 2012 12:00:00 AM GMThttp://www.medscape.com/viewarticle/775598The 32-mg, single IV dose of ondansetron hydrochloride no longer will be marketed because of the potential for serious cardiac risks, according to the FDA. Ondansetron hydrochloride (Zofran, GlaxoSmithKline) has been used to prevent chemotherapy-induced nausea and vomiting. The FDA issued a drug safety communication in June urging clinicians to stop using the 32-mg, single IV dose due to the risk for...Fri, 07 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281421&full=1SALT LAKE CITY, Dec. 5, 2012 (GLOBE NEWSWIRE) -- LifeVantage Corporation (LFVN) announced today that it is contacting affected independent distributors and other customers to voluntarily recall and replace bottles of its Protandim(R), the Nrf2 Synergizer(R), dietary supplement from the lots shown below. The Company is taking this action due to the possible inclusion of small metal fragments in the...Thu, 06 Dec 2012 12:00:00 AM GMThttp://www.pharmalot.com/2012/11/fda-rejects-request-to-ban-lice-shampoo-for-kids/After more than two years of deliberation, the FDA has rejected a request to halt the use of an insecticide in pharmaceutical treatments for head lice in children. Known commercially as Lindane, the chemical has been widely used as an agricultural tool around the world, but is also a key component in a topical lotion and shampoo that are approved by the FDA for combating lice and scabies, although...Fri, 30 Nov 2012 12:00:00 AM GMThttp://www.business-standard.com/india/news/aurobindo-drug-recalled-inus/493654/On Friday, Ranbaxy Laboratories voluntarily recalled a few batches of generic Lipitor from the US market. But the Gurgaon-based company is not the only Indian drugmaker to voluntarily recall drugs from the US market this year. An enforcement report brought out by the US Food and Drugs Administration (FDA) on November 14 shows Hyderabad-based Aurobindo Pharma voluntarily recalled a batch of Zolpidem...Thu, 29 Nov 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/11/23/us-india-ranbaxy-recall-idUSBRE8AM03620121123Memories of Ranbaxy Laboratories Ltds long-drawn effort to end compliance-related issues with the US Food and Drug Administration (FDA) at some of its plants appear to be still fresh in investors minds. The company is complying with the terms of a consent decree signed with the US regulator to settle these issues and a formal closure is still awaited. But, something else grabbed investor attention...Tue, 27 Nov 2012 12:00:00 AM GMThttp://www.nytimes.com/2012/11/15/business/5-hour-energy-is-cited-in-13-death-reports.htmlThe U.S. Food and Drug Administration confirmed on Wednesday the receipt of reports that another caffeine drink, 5-hour Energy, may have been involved in a number of deaths - in this case 13 over the past four years.<br><br>The reports were first detailed by the New York Times on Wednesday.Fri, 16 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=278647&full=1RIDGEFIELD, Conn.</span>, <span class"xn-chron">Nov. 7, 2012</span> /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that it is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp <span class"xn-chron">January 2015</span>. PRADAXA is indicated to reduce...Wed, 07 Nov 2012 12:00:00 AM GMThttp://www.in-pharmatechnologist.com/Regulatory-Safety/GSK-pulls-vaccine-batch-in-Canada-over-contamination-concerns/?utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily&c=O9UEY0kQrNO6Y1F0skb6MpY3fDMNPpUNGSK has withdrawn another lot of its Infanrix Hexa vaccine over concerns about potential microbial contamination. Wed, 07 Nov 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/11/02/us-pradaxa-boehringer-idUSBRE8A114Z20121102The risk of serious bleeding among new users of Pradaxa, a blood-clot preventer made by Germany's Boehringer Ingelheim, appeared to be no higher than in patients on the widely used standard blood thinner warfarin, U.S. regulators said.<br><br>The announcement Friday by the U.S. Food and Drug Administration may allay some safety concerns about Pradaxa, a pill developed by the privately held drugmaker...Fri, 02 Nov 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/10/31/us-novartis-flu-idUSBRE89U13O20121031Canadian and Swiss health authorities lifted a ban on Novartis's flu vaccines on Wednesday after the drugmaker showed they posed no risk to safety.<br><br>Italy last week banned the sale of four anti-influenza vaccines produced by Novartis pending tests for possible side effects after small particles were found in some of the injections.Thu, 01 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277925&full=1Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.<br><br>During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be...Thu, 01 Nov 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/10/26/france-novartis-flu-idUSL5E8LQAQY20121026<a href"http://www.biospace.com/company_profile.aspx?CompanyId1011873&typepartner&sourceNewsStoryProfile"><b>Novartis</b></a> | <a href"http://www.biospace.com/jobs/search-results/CustomerId209270?typepartner&sourceNewsStoryJobs"><b>Jobs at Novartis Pharmaceuticals</b></a><br><br>France said it was halting sales of an influenza vaccine made by Swiss drugmaker <a href"http://www.biospace...Fri, 26 Oct 2012 12:00:00 AM GMThttp://www.foxnews.com/health/2012/10/24/italy-bans-novartis-flu-vaccines-pending-tests/<a href"http://www.biospace.com/company_profile.aspx?CompanyId1340&typepartner&sourceNewsStoryProfile"><b>Novartis Pharmaceuticals Corporation</b></a> | <a href"http://www.biospace.com/jobs/search-results/CustomerId209270?typepartner&sourceNewsStoryJobs"><b>Jobs at Novartis Pharmaceuticals Corporation</b></a><br><br>The Italian health ministry said on Wednesday that it had imposed an...Thu, 25 Oct 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/10/23/roche-europe-idUSL5E8LN8OT20121023Three months after the European Medicines Agency found that Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths, the agency is now initiating what its calls an infringement procedure at the request of the European Commission. The move means that Roche faces financial penalties if the EMA finds violations of pharmacovigilance...Thu, 25 Oct 2012 12:00:00 AM GMThttp://www.dailylocal.com/article/20121011/NEWS01/121019900/portfolio-improper-use-of-endo-drug-could-cause-deathPeople who abuse the prescription pain drug Opana ER by injecting it into their bloodstream risk developing a serious blood disorder that could result in kidney failure or death, U.S. health regulators warned on Thursday. Opana, a powerful opioid painkiller containing oxymorphone, is produced by Endo Pharmaceuticals. The blood disorder, thrombotic thrombocytopenic purpura, resulted in kidney failure...Mon, 15 Oct 2012 12:00:00 AM GMThttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322966.htm?source=govdeliveryOctober 08, 2012 -- AUDIENCE: Pharmacy, Risk Manager</p><p>ISSUE: FDA and Hospira announced it is initiating a voluntary user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09. This action is due to one confirmed customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and...Tue, 09 Oct 2012 12:00:00 AM GMThttp://www.telegraph.co.uk/health/healthnews/9594565/700000-travellers-at-risk-of-typhoid-due-to-dud-jab.htmlSanofi Pasteur MSD, the vaccine joint venture of Sanofi and Merck & Co, has recalled some batches of its typhoid vaccine because of concerns about effectiveness, Britain's drug regulator said on Monday. The decision to recall 16 batches of Typhim Vi follows filling problems in the manufacturing process, according to the Medicines and Healthcare Products Regulatory Agency.Tue, 09 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=275048&full=1White Plains, NY (PRWEB) October 04, 2012 -- Are all generic drugs therapeutically equivalent to their brand name counterparts? Until yesterday, the FDA, and many others, adamantly said they were. In an unprecedented move Wednesday afternoon, the FDA admitted that a generic version of the popular antidepressant Wellbutrin XL 300 mg, marketed since 2006 as Budeprion XL 300 mg by Teva Pharmaceuticals...Tue, 09 Oct 2012 12:00:00 AM GMThttp://www.theaustralian.com.au/news/breaking-news/avoid-drugs-from-company-tied-to-meningitis-fda/story-fn3dxix6-1226488848658The government is warning doctors and hospitals not to use any product from the specialty pharmacy that made the steroid suspected in a meningitis outbreak. An official with the Food and Drug Administration said tests found contamination in a sealed vial of the steroid at the New England Compounding Center in Massachusetts. Tests are under way to determine if it is the same fungus blamed in the outbreak...Mon, 08 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=273817&full=1PARSIPPANY, N.J.</span>, <span class"xn-chron">Sept. 21, 2012</span> /PRNewswire/ -- Watson Laboratories, Inc. today issued a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg. A customer complaint was received for tablets that were thicker and darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed...Mon, 24 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=273959&full=1<div class"xn-content"><p align"left"><span class"xn-location">BELLEVILLE, ON</span>, <span class"xn-chron">Sept. 20, 2012</span> /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that one of its equine products - <i>HIPPIRON^TM1000 </i>- has been counterfeited, and was discovered...Mon, 24 Sep 2012 12:00:00 AM GMThttp://www.webmd.com/parenting/baby/news/20120918/fda-to-parents-dont-use-simplythick-for-infantsA product used to help infants with difficulty swallowing could increase their risk of developing a life-threatening illness, the Food and Drug Administration warned Tuesday. The agency says 22 infants developed necrotizing enterocolitis (NEC) after being fed the thickening agent SimplyThick reportedly as directed. Seven of them died. Necrotizing enterocolitis is a condition where tissue in the...Thu, 20 Sep 2012 12:00:00 AM GMThttp://www.cardiovascularbusiness.com/index.php?option=com_articles&view=article&id=35204:fda-parkinsons-drug-may-have-possible-risk-of-heart-failureSeptember 19, 2012 -- AUDIENCE: Neurology</p><p>ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure...Thu, 20 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=273376&full=1BEDFORD, Ohio</span>, <span class"xn-chron">Sept. 18, 2012</span> /PRNewswire/ -- Bedford Laboratories today announced the expansion of its previous nationwide voluntary recall for Leucovorin Calcium Liquid Injection: </p><div><table style"BORDER-BOTTOM: 1pt; BORDER-LEFT: 1pt; BORDER-COLLAPSE: collapse; BORDER-TOP: 1pt; BORDER-RIGHT: 1pt" border"1" cellspacing"0" cellpadding"0"><tr...Tue, 18 Sep 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/09/13/us-fda-warning-painreliever-idUSBRE88C0UT20120913Over-the-counter muscle and joint pain relievers may cause chemical burns in rare cases, U.S. health regulators warned on Thursday. Products that contain menthol, methyl salicylate, or capsaicin including major brands such as Johnson & Johnson's Bengay, Sanofi's Icy Hot, Capzasin and Flexall, and Rohto Pharmaceutical Co's Mentholatum were found to cause first- to third-degree burns. "These products...Mon, 17 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=272657&full=1 <div class"xn-content"><p><span class"xn-location">HUNTSVILLE, Ala.</span>, <span class"xn-chron">Sept. 10, 2012</span> /PRNewswire/ -- Qualitest, a subsidiary of Endo Health Solutions (Nasdaq: ENDP), today issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. </p><p>The recall includes the following product lot:<...Tue, 11 Sep 2012 12:00:00 AM GMThttp://www.washingtonpost.com/business/bristol-myers-recalling-more-than-31000-vials-of-chemotherapy-drug-due-to-overfill-risk/2012/08/30/75fa2294-f2b7-11e1-b74c-84ed55e0300b_story.htmlPRINCETON, N.J., August 30, 2012 - Bristol-Myers Squibb Company (NYSE: BMY) has initiated a voluntary recall nationwide of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, Inc., a former, third-party contract manufacturer for the company, to the user level. The precautionary recall of BiCNU, a chemotherapeutic agent administered to patients in a hospital...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=271835&full=1CRANBURY, N.J.</span>, <span class"xn-chron">Sept. 4, 2012</span> /PRNewswire/ -- Sun Pharmaceutical Industries, Inc. (Sun Inc) announced today that it is voluntarily recalling from users one lot of Nimodipine Capsules, 30 mg, marketed by Caraco Pharmaceutical Laboratories, Ltd. Sun Inc. commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/08/30/us-fda-pfizer-revatio-idUSBRE87T1L820120830U.S. health regulators recommended against use of Pfizer Inc's pulmonary arterial hypertension (PAH) drug Revatio in children up to 17 years of age, saying it had a higher risk of death when taken in a high dose. While the drug has never been approved for treatment of PAH in children, the U.S. Food and Drug Administration's warning is against off-label use of the drug. Revatio, which has the same active...Fri, 31 Aug 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/08/29/us-vertexpharmaceuticals-idUSBRE87S0Q520120829The Food and Drug Administration is warning doctors, parents and patients about the potential for eye disorders linked to Kalydeco, a groundbreaking treatment for cystic fibrosis approved earlier this year. The FDA says the warning is based on cases of cataract seen in juvenile rats studied by the drug's manufacturer, Vertex Pharmaceuticals. The study was designed to show that Kalydeco is safe for...Thu, 30 Aug 2012 12:00:00 AM GMT