Recent Event Highlights: FDA Basics: Dr. Margaret Oeller on FDA's Office of Minor Use and Minor Species, Recall of Certain LIFEPAK Defibrillators, FDA Requirements for Colleague Infusion Pump Recall, Matrixx Initiatives F3Q10 (Qtr End 12/31/09) Earnings Call Transcript - Seeking Alpha (blog), Matrixx Initiatives, Inc. Reports Fiscal 2010 Third Quarter Sales of $28.5 ... - PR Newswire (press release), Toyota Recall - Puggal Latest News and events, and 25 more...
Created by dipity on Jun 16, 2009
Last updated: 06/05/11 at 08:26 PM
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While tidying-up the computer over the weekend, I found some video that I forgot about. Shot several months ago while in Moscow for a few days. The concierge highly recommended taking a cab, but I wanted to spend time exploring Russia alone on foot. So he pointed me in the direction of Red Square, and I was off. 20 minutes into the walk, I wish I took the cab. I learned that they don't clean off sidewalks much in Russia. My feet were soaked from slush, but I trudged forth. An hour later, I was in Red Square. It was emotionally powerful. I found a nice coffee shop to spend some time in. I got back to my hotel 5 hours later... which was long since it was freezing and I had wet feet the whole time. But worth it. Doubled up on the D3, C, and Zicam for a few days, and never even got sick. Also Arma 17 Nightclub and cab to / from airport. One thing I recall about this trip... I went from Moscow to Amsterdam for a week before going home. I got to my hotel in Amsterdam, crashed, and while having breakfast the next morning, I watched a television news-flash about a major bombing in Moscow where 40 people were killed and 100 injured. I was watching areas of Moscow where I spent the previous 4 days walking around. The Moscow Metro was hit by Suicide Bombers the day that I flew out. Especially scary since my hosts were encouraging me to stay in Moscow longer. I didn't shoot much video here because Moscow has regulations about open photography with "professional cameras". If your lens ...
The Food & Drug Administration's Office of Minor Use and Minor Species Animal Drug Development works with other government agencies and industry to develop and approve pharmaceuticals for so called minor species; zoo and circus animals, exotic animals, and farm animals, such as goats and sheep.
Physio-Control has alerted users of LIFEPAK 20 and LIFEPAK 20e defibrillators about possible failures in AC or DC power that could delay or prevent these devices from delivering therapy. If a failure occurs while the device is being used in the AC or line-power mode, the unit should automatically switch to the DC, or battery mode. But after the battery is depleted, the AC failure will prevent the battery from recharging and all power will be lost. All power could also be lost if a failure occurs in the DC, or battery mode and the user cannot plug the unit into an AC source. The company says that it will update the power supplies on the affected devices. In the meantime, users should keep the units in service if they are functioning normally. It is important to inspect and test the devices every day according to the company's operating instructions, because that can help identify potential power failures. If possible, the units should be kept connected to an AC source with the batteries charged. For more information, contact Physio-Control Technical Support at 1-800-442-1142. FDA Patient Safety News: September 2010 For more information, please see our website: www.accessdata.fda.gov
Hospira is expanding a recall of several of the company's injectable products because some of the containers may contain particulate matter, which consists mainly of inert stainless steel particles that are not visible. Because these particulates do not dissolve in blood, they could potentially act as emboli and impede blood flow or cause mechanical damage to the body. This recall, which broadens the company's first action on March 31, 2010, affects a number of lots of Hospira's propofol injectable emulsion 1%. It also affects Liposyn products, including Liposyn II in 10 and 20 percent, and Liposyn III in 10, 20 and 30 percent. Anyone who has propofol or Liposyn from the recalled lots should not use or distribute it further. Quarantine the products immediately and arrange for a return by calling 1-877-884-7835. The company is working with FDA to address the issues that led to the recall, and will distribute new product as it becomes available. FDA Patient Safety News: September 2010 For more information, please see our website: www.accessdata.fda.gov
Here is information on the steps Baxter Healthcare has to take in order to carry out the recall of its Colleague volumetric infusion pumps. The recall was ordered by FDA earlier this year because of Baxter's long-term failure to correct serious problems with Colleague pumps. Baxter is required to give Colleague pump owners a cash refund or a replacement pump at no charge. Also, facilities that lease Colleague pumps may terminate the lease without penalty. The company must also give a full refund for unused Colleague pump spare parts, batteries, and consumables. The company's Transition Guide will give details on the refund or replacement program, provide a list of alternative pumps, and offer suggestions to help minimize disruption and patient risks during the transition period. The Guide will be issued no later than September 11, 2010. Baxter's guide will also describe how to fill out a Certificate of Medical Necessity. It is important to submit this certificate by November 14, 2010 in order to receive a replacement or refund, and so that Baxter can continue to provide service and maintenance for existing units. Baxter is required to complete the transition by July 14, 2012. After that, they must stop all service and support for Colleague products. Until then, clinicians and home-care users can continue to use their Colleague pumps, and Baxter will continue to provide service and maintenance. But FDA recommends replacing the pumps as soon as it is safely possible. For ...
Matrixx Initiatives F3Q10 (Qtr End 12/31/09) Earnings Call TranscriptSeeking Alpha (blog)Consumers are responding to our advertising and promotional active programs and are looking to the Zicam brand to get over their colds faster. ...and more »
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Matrixx Initiatives, Inc. Reports Fiscal 2010 Third Quarter Sales of $28.5 ...PR Newswire (press release)Bill Hemelt, President and Chief Executive Officer, said, "With the discontinuance of our nasal Cold Remedy products, we are pleased that our Zicam Cold ...Q3 income falls 26% for cold-remedy maker MatrixxArizona Republicall 23 news articles »
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Toyota RecallPuggal Latest News and eventsChrysler Recall The Chrysler Group is recalling 24000 of their Dodge... Zicam Case Recall On 16th June, 2009 the Zicam Cold Remedy case report. ...and more »
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Pharmaceutical Recalls in 2009InjuryBoard.com (blog)Several versions of the Zicam cold remedy were also recalled in 2009, because of numerous reports of individuals losing their sense of smell. The recall ...
http://news.google.com/news/url?fd=R&sa=T&url=http%3A%2F%2Forlando.injuryboard.com%2Ffda-and-prescription-drugs%2Fpharmaceutical-recalls-in-2009.aspx%3Fgoogleid%3D276994&usg=AFQjCNHvdkLN0zNak2n9lh4hZQrJ95dFww
Chrysler RecallPuggal Latest News and eventsStorkcraft Crib Recall Stork Craft Manufacturing Inc, of British Columbia and Canada... Zicam Case Recall On 16th June, 2009 the Zicam Cold Remedy case ...and more »
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Zicam Loss of Smell Lawsuit Filed Over Recalled Nasal Spray Cold RemedyAboutLawsuits.comAll of the lawsuits involve claims that Zicam caused users to lose some or all of their sense of smell or taste. Matrixx Initiatives issued the Zicam recall ...
http://news.google.com/news/url?fd=R&sa=T&url=http%3A%2F%2Fwww.aboutlawsuits.com%2Fzicam-loss-of-smell-lawsuit-filed-7631%2F&usg=AFQjCNEi4hDxUX7v_ws3q-Totkp73fV9Qw
Excerpt
...until the FDA issued a release on June 16, 2009, advising consumers to stop using Matrixx's product did Matrixx recall Zicam, the complaint says. In her 10-count suit, Bollone seeks a judgment of more than $500,000, plus costs and other relief the court deems...
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The Madison Record
http://feedproxy.google.com/~r/madisonrecord/QDtS/~3/_hex9qZzVjw/224056-zicam-and-manufacturer-blamed-for-womans-loss-of-smell-taste
Zicam and manufacturer blamed for woman's loss of smell, tasteSt. Clair RecordNot until the FDA issued a release on June 16, 2009, advising consumers to stop using Matrixx's product did Matrixx recall Zicam, the complaint says. ...and more »
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Matrixx taps Phoenix firm for brand strategyAZ Central.comThe nasal spray is the only Zicam product targeted for recall and by consumers claiming loss of smell and/or taste. Cramer-Krasselt will oversee brand ...and more »
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Zicam Makers to Spend $30 Million With New Ad FirmAttorney at Law... Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids Size – were involved in the subsequent FDA recall. ...and more »
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www.tilpc.com
www.tilpc.com ... Alabama Mobile Personal Injury Lawyers attorneys lawyer attorney "Earle Long" "Dean Waite" accident "18 wheeler" wreck crash auto car defective product drug recall fatal hydroxycut insurance bad faith medical malpractice negligence mesothelioma motorcycle nursing home negligent neglect premises liability social security trasyol brain truck vioxx "workers compensation" "workers comp" zicam wrongful death
www.tilpc.com ... Alabama Mobile Personal Injury Lawyers attorneys lawyer attorney "Earle Long" "Dean Waite" accident "18 wheeler" wreck crash auto car defective product drug recall fatal hydroxycut insurance bad faith medical malpractice negligence mesothelioma motorcycle nursing home negligent neglect premises liability social security trasyol brain truck vioxx "workers compensation" "workers comp" zicam wrongful death 16 years experience
www.tilpc.com
www.tilpc.com ... Alabama Mobile Personal Injury Lawyers attorneys lawyer attorney "Earle Long" "Dean Waite" accident "18 wheeler" wreck crash auto car defective product drug recall fatal hydroxycut insurance bad faith medical malpractice negligence mesothelioma motorcycle nursing home negligent neglect premises liability social security trasyol brain truck vioxx "workers compensation" "workers comp" zicam wrongful death
www.tilpc.com
www.tilpc.com ... Alabama Mobile Personal Injury Lawyers attorneys lawyer attorney "Earle Long" "Dean Waite" accident "18 wheeler" wreck crash auto car defective product drug recall fatal hydroxycut insurance bad faith medical malpractice negligence mesothelioma motorcycle nursing home negligent neglect premises liability social security trasyol brain truck vioxx "workers compensation" "workers comp" zicam wrongful death
www.tilpc.com
Excerpt
...that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who use them.” The FDA issued a recall : , alerting the public that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued...
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PR-Inside.com
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http://www.pr-inside.com/weitz-amp-luxenberg-lawyers-highlight-study-r1590453.htm
FDA has issued a warning that zinc-containing cold remedies administered directly into the nose have been associated with anosmia, which is a loss of the sense of smell. This warning is directed at several over-the-counter products marketed by Matrixx Initiatives: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs Kids Size, which has been discontinued. FDA is advising people to stop using them. FDA has received more than 130 reports of anosmia in ...
Excerpt
...on the other hand a US consumer has lost their sense of taste or smell within the last three years after using the recalled Zicam products, please call the US Drug Watchdog immediately at 866-714-6466, or contact the group via its web site at Http://USDrugWatchdog.Com According...
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Emediawire.com
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http://www.prweb.com/releases/2009/08/prweb2731244.htm
Excerpt
...because they are associated with the loss of sense of smell (anosmia). Even worse, the group says, "we fear there may be recalled Zicam products in millions of US households, & we want people who read this press release, to share it with everyone they know."The...
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Emediawire.com
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http://www.prweb.com/releases/2009/08/prweb2705204.htm
Excerpt
... The FDA advised consumers to stop using Matrixx Initiatives' Zicam products in mid-June. The zinc in Zicam swabs and gel could possible damage the sense of smell. The company's voluntary recall commenced on June 24th, shortly after a handful of class action...
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TransWorldNews
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http://www.transworldnews.com/NewsStory.aspx?storyid=100534
Excerpt
...The FDA also says that Maatrix never handed over 800 internal complaints from consumers who suffered asomnia after using Zicam. The recall covered both the gel and swab versions of Zicam. In a filing with the Securities and Exchange Commission (SEC), Maatrix...
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Consumer Affairs
http://www.consumeraffairs.com/news04/2009/07/zicam_class.html
www.burke-eisner.com More Information on the Nose Spray Recall. Leegal Info and Options
Rush telling his usual BS.
Excerpt
...MTXX) has announced that it is in the process of formally notifying retailers, wholesalers and distributors nationwide of its recall of all Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs. Matrixx Initiatives vigorously disagrees with the FDA's...
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Street Insider
http://www.streetinsider.com/FDA/Matrixx+Initiatives+%28MTXX%29+Confirms+Voluntary+Recall+of+Zicam/4751387.html
www.burke-eisner.com Nose Spray Recall Information
Brad and Lily discuss the pros and cons of the sense of smell.
If homeopathy worked, Zicam would be too weak to do anything. Turns out it's strong enough to destroy your sense of smell. Story: www.nytimes.com The music is preview.tinyurl.com twitter.com www.facebook.com myspace.com
Excerpt
...products under the FDA warning, Call7 found the response by local retailers was slow. The FDA does not have the authority to recall an item, but their warning to Matrixx Initiatives, the makers of Zicam, resulted in the company pulling the products. The company...
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The Denver Channel
http://www.thedenverchannel.com/news/19782918/detail.html
zicam, zicam loss of smell, zicam warning, zicam nasal spray, zicam side effects The FDA (Food and Drug Administration) has issued a warning on three zinc-containing Zicam intranasal products. The Zicam recall goes into effect immediately, today, June 16, 2009, the products are being recalled due to more than 130 reports of anosmia, or loss of sense of smell after use. The three products in question are:
personalmoneystore.com Rumors of a Zicam recall are circulating rapidly, since the FDA issued a warning today about Zicam. There have been enough reports of anosmia (total loss of sense of smell) and hyposmia (partial smell loss) that the FDA is now warning consumers not to use or to stop using Zicam Cold Remedy nasal gel. Read the full article at... personalmoneystore.com
Excerpt
...Initiatives’ shares are falling on news of a Zicam FDA warning (not a recall). The Zicam FDA warning from side effects symptoms has causes the shares of Matrixx to fall $10.68, 50%, on the NASDAQ until trading was haulted. This is the stock’s lowest level...
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Lalate News
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http://news.lalate.com/2009/06/16/zicam-fda-matrixx/
The Information you NEED, but the press didn't tell you! The Food and Drug Administration says Zicam nasal spray can PERMANENTLY damage users' sense of smell. The FDA says consumers should stop using it at once!
Excerpt
...intranasal spray Zicam is being recalled as the Food & Drug Administration warns of 130 cases of anosmia- loss of the sense of smell. Some Zicam users reporting anosmia say that the condition started with the first dose, while others indicate the symptoms...
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The Inquisitr
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http://feedproxy.google.com/~r/inquisitr/~3/po2FqpMKIi0/
This is the second video for what annoys us about girls! ... Zicam "zicam recall"
Excerpt
...the costs of the product recall; (iii) our expectations regarding sales in Canada and the introduction of several additional Zicam products in Canada during the fiscal third quarter; (iv) our expectations regarding product liability defense costs; (v) our...
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PR Newswire
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http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/10-22-2008/0004908944&EDATE=
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