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	<title>Drug Lawsuits &#124; Drug Attorneys &#38; Lawyers</title>
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	<link>http://www.drug-attorneys.com</link>
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		<title>Accutane Crohn&#8217;s Disease, Ulcerative Colitis and IBD Lawsuits</title>
		<link>http://www.drug-attorneys.com/drugs/accutane-crohns-disease-ulcerative-colitis-and-ibd-lawsuits-03172010</link>
		<comments>http://www.drug-attorneys.com/drugs/accutane-crohns-disease-ulcerative-colitis-and-ibd-lawsuits-03172010#comments</comments>
		<pubDate>Wed, 17 Mar 2010 13:00:52 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[Drugs]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=475</guid>
		<description><![CDATA[Accutane (isotretinoin), or Roaccutane as it is known in other parts of the world, was discovered in 1979 and released in 1982 by Hoffmann-La Roche. Accutane was given to patients to treat severe acne because it affects all four ways that acne develops. Most Accutane patients reacted with dramatic and permanent clearing of their acne [...]]]></description>
			<content:encoded><![CDATA[<p><img src="/images/drug-attorneys/drugs/accutane.jpg" align="left" alt="Accutane">Accutane (isotretinoin), or Roaccutane as it is known in other parts of the world, was discovered in 1979 and released in 1982 by Hoffmann-La Roche. Accutane was given to patients to treat severe acne because it affects all four ways that acne develops. Most Accutane patients reacted with dramatic and permanent clearing of their acne symptoms. Accutane is a vitamin A derivative (13-cis-retinoic acid) which is administered orally in pill form, for 15 to 20 weeks. Accutane was originally only prescribed to patients with severe acne that did not respond to other forms of acne treatments. However, over the past 25 years Accutane has gained in popularity and is being prescribed not only more frequently, but also for less severe acne. This practice is controversial because Accutane increases a patient&#8217;s risk of developing serious side effects such as Crohn&#8217;s disease (CD), ulcerative colitis (UC), and inflammatory bowel disease (IBD).</p>
<h2>Speak to an Accutane Lawyer</h2>
<p>If you took Accutane and developed Crohn&#8217;s disease (CD), ulcerative colitis (UC), or inflammatory bowel disease (IBD), we encourage you to contact an Accutane litigation attorney at our law firm immediately. It may be too late to recover from the debilitating effects of Accutane, but an experienced product liability attorney can assist you in a legal action against the makers of Accutane, Roche Laboratories. You are not alone. Join other Crohn&#8217;s disease (CD), ulcerative colitis (UC), or inflammatory bowel disease (IBD) victims and their families in fighting for their legal rights.</p>
<p>Please fill out our free legal evaluation form on the far right and we will call or e-mail you back within 24 hours. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file an Accutane lawsuit or seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.</p>
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		<title>Baby Slings Can Cause Infant Suffocation</title>
		<link>http://www.drug-attorneys.com/fda-reports/fda-alerts/baby-slings-can-cause-infant-suffocation-03122010</link>
		<comments>http://www.drug-attorneys.com/fda-reports/fda-alerts/baby-slings-can-cause-infant-suffocation-03122010#comments</comments>
		<pubDate>Fri, 12 Mar 2010 13:00:13 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[FDA Alerts]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=462</guid>
		<description><![CDATA[The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve [...]]]></description>
			<content:encoded><![CDATA[<p>The U.S. Consumer Product Safety Commission (CPSC) is advising parents and caregivers to be cautious when using infant slings for babies younger than four months of age. In researching incident reports from the past 20 years, CPSC identified and is investigating at least 14 deaths associated with sling-style infant carriers, including three in 2009. Twelve of the deaths involved babies younger than four months of age.</p>
<p><img src="/images/drug-attorneys/medical-devices/baby-sling-warnings.jpg" align="center" alt="Baby Sling Warnings"><br />
<br clear="all"/></p>
<p>Slings can pose two different types of suffocation hazards to babies. In the first few months of life, babies cannot control their heads because of weak neck muscles. The sling’s fabric can press against an infant’s nose and mouth, blocking the baby’s breathing and rapidly suffocating a baby within a minute or two. Additionally, where a sling keeps the infant in a curled position bending the chin toward the chest, the airways can be restricted, limiting the oxygen supply. The baby will not be able to cry for help and can slowly suffocate. </p>
<p>Many of the babies who died in slings were either a low birth weight twin, were born prematurely, or had breathing issues such as a cold. Therefore, CPSC urges parents of preemies, twins, babies in fragile health and those with low weight to use extra care and consult their pediatricians about using slings.</p>
<p>Two months ago, the Commission added slings to the list of durable infant products that require a mandatory standard. Additionally, CPSC staff is actively investigating these products to determine what additional action may be appropriate. Until a mandatory standard is developed, CPSC is working with ASTM International to quickly complete an effective voluntary standard for infant sling carriers.</p>
<p>CPSC recommends that parents and caregivers make sure the infant’s face is not covered and is visible at all times to the sling’s wearer. If nursing the baby in a sling, change the baby’s position after feeding so the baby’s head is facing up and is clear of the sling and the mother’s body. Parents and caregivers should be vigilant about frequently checking their baby in a sling.</p>
]]></content:encoded>
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		<item>
		<title>Fosamax Femur Fracture Lawsuits</title>
		<link>http://www.drug-attorneys.com/drugs/fosamax-femur-fracture-lawsuits-03092010</link>
		<comments>http://www.drug-attorneys.com/drugs/fosamax-femur-fracture-lawsuits-03092010#comments</comments>
		<pubDate>Tue, 09 Mar 2010 13:00:53 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[Drugs]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=449</guid>
		<description><![CDATA[Fosamax (alendronate sodium) is an osteoporosis drug manufactured by Merck to treat bone loss. Fosamax is prescribed to millions of people to reduce the risk of bone fractures, primarily involving the hip. Hundreds of Fosamax lawsuits have already been filed by consumers who experienced severe side effects from taking Fosamax. These side effects included a [...]]]></description>
			<content:encoded><![CDATA[<p><img src="/images/drug-attorneys/drugs/fosamax.jpg" align="left" alt="Fosamax">Fosamax (alendronate sodium) is an osteoporosis drug manufactured by Merck to treat bone loss. Fosamax is prescribed to millions of people to reduce the risk of bone fractures, primarily involving the hip. Hundreds of Fosamax lawsuits have already been filed by consumers who experienced severe side effects from taking Fosamax. These side effects included a rare decay of the jawbone known as osteonecrosis of the jaw, or ONJ. Recently, a medical study linked Fosamax to a rare type of bone fracture in the femur.</p>
<h2>Medical Study Links Fosamax to Femur Bone Fracture</h2>
<p><img src="/images/drug-attorneys/femur-fracture.jpg" align="right" alt="Femur Fracture">A medical study in the <em>Journal of Orthopedic Trauma</em> links Fosamax to a rare type of fracture in the femur. The small, observational study looked at 70 patients who experienced low-energy femur fractures, which occur when someone falls from a standing height or less. Twenty-five patients (36%) were taking Fosamax on average for four years or more. The Fosamax patients&#8217; fractures had some distinct characteristics: nineteen (76%) of the 25 patients had a simple fracture with a straight line across the bone and a beak-like overhang on one side. Also, the patients&#8217; bones didn&#8217;t look like typical osteoporotic bone; they looked strong.</p>
<h2>Merck Disagrees with Fosamax Fracture Femur Medical Study</h2>
<p>Merck pointed out that Fosamax and other bisphosphonate medications have been shown to decrease the risk of a type of femur fractures common in patients with osteoporosis. In a statement on the new study, Merck said that &#8220;a causal association with bisphosphonates and either the fracture pattern or the frequency of these fractures has not been established by the authors.&#8221;</p>
<h2>Speak to a Fosamax Lawyer</h2>
<p>If you took Fosamax and suffered osteonecrosis of the jaw (ONJ), a broken leg, or femur fracture, we encourage you to contact a Fosamax attorney at our law firm immediately. An experienced product liability attorney can assist you in a legal action against the makers of Fosamax. Contact our law firm and learn more about your legal rights and the options available to you and your family.</p>
]]></content:encoded>
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		<item>
		<title>Cold Therapy Lawsuits</title>
		<link>http://www.drug-attorneys.com/medical-devices/cold-therapy-lawsuits-03042010</link>
		<comments>http://www.drug-attorneys.com/medical-devices/cold-therapy-lawsuits-03042010#comments</comments>
		<pubDate>Thu, 04 Mar 2010 13:00:10 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[Medical Devices]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=430</guid>
		<description><![CDATA[Cold Therapy Machines Under Investigation
Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have [...]]]></description>
			<content:encoded><![CDATA[<h2>Cold Therapy Machines Under Investigation</h2>
<p>Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:</p>
<ul>
<li>DonJoy Cold Therapy Machines</li>
<li>PolarCare Cold Therapy Machines</li>
<li>EBIce Cold Therapy Machines</li>
</ul>
<p>Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.</p>
<h2>Cold Therapy Attorney</h2>
<p>If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to an attorney for legal advice about a potential cold therapy lawsuit.</p>
]]></content:encoded>
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		<title>Cold Therapy Nerve Damage Lawsuits</title>
		<link>http://www.drug-attorneys.com/medical-devices/cold-therapy-nerve-damage-lawsuits-02242010</link>
		<comments>http://www.drug-attorneys.com/medical-devices/cold-therapy-nerve-damage-lawsuits-02242010#comments</comments>
		<pubDate>Wed, 24 Feb 2010 13:00:46 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[Medical Devices]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=435</guid>
		<description><![CDATA[Prolonged exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment may cause skin damage, permanent nerve damage, and chronic pain to patients. A case report entitled, Cryotherapy Can Cause Permanent Nerve Damage, was published in the American Journal of Pain Management in April of 2004. The case study [...]]]></description>
			<content:encoded><![CDATA[<p><img src="/images/drug-attorneys/medical-devices/cold-therapy-donjoy.jpg" align="left" alt="Cold Therapy Donjoy">Prolonged exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment may cause skin damage, permanent nerve damage, and chronic pain to patients. A case report entitled, <em>Cryotherapy Can Cause Permanent Nerve Damage</em>, was published in the American Journal of Pain Management in April of 2004. The case study describes the cold therapy side effects of a patient who had undergone repetitive and prolonged cryotherapy (application of ice), and cryosurgery (cryoablation).</p>
<h2>Cold Therapy Side Effects</h2>
<p>Cold therapy side effects may include one or more of the following:</p>
<ul>
<li>Skin damage</li>
<li>Nerve damage</li>
<li>Wrist, ankle, shoulder or back injury</li>
<li>Hand amputation</li>
<li>Foot amputation</li>
<li>Loss of a limb</li>
<ul>
<li>Arm amputation</li>
<li>Leg amputation</li>
</ul>
<li>Complex Regional Pain Syndrome (CRPS)</li>
<ul>
<li>CRPS 1 (chronic nerve disorder in the arms or legs after a minor injury)</li>
<li>CRPS 2 (caused by an injury to the nerve)</li>
</ul>
<li>Reflex Sympathetic Dystrophy (RSD)</li>
<ul>
<li>Reflex Sympathetic Dystrophy Syndrome (RSDS)</li>
<li>Complex Regional Pain Syndrome</li>
<li>Shoulder-Hand Syndrome</li>
<li>Causalgia</li>
<li>Sudeck&#8217;s Atrophy</li>
</ul>
</ul>
<h2>Cold Therapy Machines Under Investigation</h2>
<p>Chronic pain and permanent nerve damage resulting from exposure to cold therapy, ice machines, recirculating ice coolers, cryotherapy and other forms of cold treatment are why numerous consumers are filing cold therapy lawsuits. Several manufacturers of cold therapy machines are being investigated for defective equipment and design flaws that may have caused cold therapy injuries to patients. Some if these cold therapy devices include:</p>
<ul>
<li>DonJoy Cold Therapy Machines</li>
<li>PolarCare Cold Therapy Machines</li>
<li>EBIce Cold Therapy Machines</li>
</ul>
<p>Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.</p>
<p>For more information regarding cold therpy lawsuits, please fill out our form on the right side of this page or give our law firm a call at our toll free number (located in the top right corner).</p>
<h2>Cold Therapy Attorney</h2>
<p>Poorly designed cold therapy machines may cause permanent skin damage (frost bite), nerve damage, and numerious other serious side effects. Seek immidiate medical attention if you are suffering an emergency situation.</p>
<p>If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to an attorney for legal advice about a potential cold therapy lawsuit.</p>
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		<item>
		<title>Depakote Spina Bifida Lawsuits</title>
		<link>http://www.drug-attorneys.com/drugs/depakote-spina-bifida-lawsuits-02012010</link>
		<comments>http://www.drug-attorneys.com/drugs/depakote-spina-bifida-lawsuits-02012010#comments</comments>
		<pubDate>Mon, 01 Feb 2010 13:00:45 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[Drugs]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=382</guid>
		<description><![CDATA[Depakote is used to treat long-term manic and depressive parts of rapidly-cycling bipolar disorder, migraines, epilepsy and chronic pain associated with nervous system diseases. Marketed by Abbott Laboratories, Depakote is a widely used drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be [...]]]></description>
			<content:encoded><![CDATA[<p><img src="/images/drug-attorneys/drugs/depakote.jpg" align="left" alt="Depakote Spina Bifida">Depakote is used to treat long-term manic and depressive parts of rapidly-cycling bipolar disorder, migraines, epilepsy and chronic pain associated with nervous system diseases. Marketed by Abbott Laboratories, Depakote is a widely used drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be aware of the risks to the fetus. Use of Depakote during pregnancy can cause congenital malformations including neural tube defects and other deformities.</p>
<h2>Depakote Side Effects</h2>
<p>Severe Depakote side effects may include:</p>
<ul>
<li>Malformations</li>
<li>Intrauterine growth retardation</li>
<li>Neural tube closure defects</li>
<li>Coarctation of the aorta</li>
<li>Atrial septal defects</li>
<li>Pulmonary stenosis</li>
<li>Hypoplastic right heart</li>
<li>Dysplastic ribs</li>
<li>Cleft palate</li>
<li>Hand malformations</li>
<li>Hydronephrosis (distention and dilation of the renal pelvis)</li>
<li>Undescended testes</li>
<li>Hypospadias (male birth defect that involves the urethral opening occurring in the wrong place)</li>
<li>Skeletal defects</li>
<li><a href="http://www.depakote-birth-defects.com/depakote-spina-bifida.html" title="Depakote Spina Bifida">Spina bifida</a></li>
<li>Spina bifida occulta</li>
<li>Spina bifida closed neural tube defects</li>
<li>Spina bifida meningocele</li>
<li>Spina bifida myelomeningocele (cystica)</li>
<li>Anencephaly</li>
<li>Rachischisis</li>
<li>Death of the newborn</li>
</ul>
<h2>Speak to a Depakote Lawyer</h2>
<p>If your child was born with severe birth defects that may have resulted from taking Depakote during pregnancy, contact our law firm immediately to discuss your legal options. Speak to a lawyer about your child&#8217;s skeletal defects, spina bifida, growth retardation or other injuries and learn about what legal options are available to your family. Our law firm has represented thousands of clients over the last twenty five years and thoroughly understands drug litigation. Contact an attorney today for a free and confidential Depakote lawsuit evaluation.</p>
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		<item>
		<title>Byetta Pancreatitis Lawsuits</title>
		<link>http://www.drug-attorneys.com/drugs/byetta-pancreatitis-lawsuits-01012010</link>
		<comments>http://www.drug-attorneys.com/drugs/byetta-pancreatitis-lawsuits-01012010#comments</comments>
		<pubDate>Fri, 01 Jan 2010 13:00:49 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[Drugs]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=377</guid>
		<description><![CDATA[The FDA has issued numerous warnings regarding Byetta side effects. Serious side effects from the use of Byetta may include acute pancreatitis, hemorrhagic pancreatitis or necrotizing pancreatitis. Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. The FDA warns that at least two people have died as a result [...]]]></description>
			<content:encoded><![CDATA[<p>The FDA has issued numerous warnings regarding Byetta side effects. Serious side effects from the use of Byetta may include acute pancreatitis, hemorrhagic pancreatitis or necrotizing pancreatitis. Pancreatitis is an inflammation of the pancreas that can cause bleeding, tissue damage and infection. The FDA warns that at least two people have died as a result of Byetta-associated pancreatitis. A severe case of pancreatitis can lead to the release of toxins and enzymes into the blood stream. These toxins can injure the heart, lungs, kidneys or other organs resulting in pancreatic death.</p>
<h2>Byetta Information</h2>
<p>Byetta is made by Amylin Pharmaceuticals Inc, and marketed jointly by Amylin and Eli Lilly &#038; Co. The drug was approved by the Food &#038; Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. While Byetta  may lower blood glucose levels on its own, it can also be combined with other medications such as pioglitazone, metformin, sulfonylureas, and/or insulin (not FDA approved yet) to improve glucose control. The approved use of exenatide is with either sulfonylureas, metformin and thiazolinediones. Byetta is injected subcutaneously twice per day using a pre-filled pen device.</p>
<h2>Byetta Lawyer</h2>
<p>If you or a loved one were prescribed Byetta and have been diagnosed with serious side effects including acute pancreatitis, necrotizing pancreatitis or hemorrhagic pancreatitis, then you may have a legal right to file a Byetta pancreatitis lawsuit. Please contact our law firm to discuss your legal options. Your initial consultation with a Byetta lawyer about your potential case is free and confidential.</p>
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		<title>Qualitest Pharmaceuticals Recalls Accusure Insulin Syringes</title>
		<link>http://www.drug-attorneys.com/news/qualitest-pharmaceuticals-recalls-accusure-insulin-syringes-10272009</link>
		<comments>http://www.drug-attorneys.com/news/qualitest-pharmaceuticals-recalls-accusure-insulin-syringes-10272009#comments</comments>
		<pubDate>Tue, 27 Oct 2009 13:00:42 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[News]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=425</guid>
		<description><![CDATA[Qualitest Pharmaceuticals Issues a Nationwide Recall of All Accusure® Insulin Syringes
Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, [...]]]></description>
			<content:encoded><![CDATA[<p><b>Qualitest Pharmaceuticals Issues a Nationwide Recall of All Accusure® Insulin Syringes</b></p>
<p>Qualitest Pharmaceuticals today issued a voluntary nationwide recall of all Accusure® Insulin Syringes. The distributed syringes are of the following descriptions and NDC numbers: 28G 1/2cc, NDC 0603-6995-21;28G 1cc, NDC 0603-6996-21; 29G 1/2cc NDC 0603-6997-21, 29G 1cc, NDC 0603-6998-21, 30G 1/2cc, NDC 0603-999-21, 30G 1cc, NDC 0603-7000-21, 31G 1/2cc, NDC 0603-7001-21; and 31G 1cc, NDC 0603-7002-21. All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe.</p>
<p>If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.</p>
<p>Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.</p>
<p>Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.</p>
<p>The recall is being made with the knowledge of the Food and Drug Administration.</p>
<p>Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.</p>
<p>Adverse reactions or quality problems experienced with the use of this product may be reported to FDA&#8217;s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.</p>
<ul>
<li>Online: <a href="http://www.fda.gov/medwatch/report.htm" target="_blank">www.fda.gov/medwatch/report.htm</a></li>
<li>Regular Mail: use postage-paid FDA form 3500 available at: <a href="http://www.fda.gov/medwatch/getforms.htm" target="_blank">www.fda.gov/medwatch/getforms.htm</a><br/>Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787</li>
<li>Fax: 1-800-FDA-0178</li>
</ul>
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		<item>
		<title>American Regent Recalls Ketorolac Tromethamine Injection</title>
		<link>http://www.drug-attorneys.com/fda-reports/fda-recalls/american-regent-recalls-ketorolac-tromethamine-injection-10202009</link>
		<comments>http://www.drug-attorneys.com/fda-reports/fda-recalls/american-regent-recalls-ketorolac-tromethamine-injection-10202009#comments</comments>
		<pubDate>Tue, 20 Oct 2009 13:00:40 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[FDA Recalls]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=423</guid>
		<description><![CDATA[American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials
American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial
NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This voluntary recall is due to the [...]]]></description>
			<content:encoded><![CDATA[<p><b>American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials</b></p>
<p>American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:</p>
<ul>
<li>NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial</li>
<li>NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)</li>
</ul>
<p>This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.</p>
<p>The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.</p>
<p>Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.</p>
<p>&#8220;Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,&#8221; said Mary Jane Helenek, President and CEO of American Regent.</p>
<p>On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.</p>
<p>While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.</p>
<p>As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, &#8220;Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.&#8221;</p>
<p>American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.</p>
<p>Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.</p>
<p>Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].</p>
<p>Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).</p>
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		<title>Unomedical Recalls Manual Pulmonary Resuscitators (MPRs)</title>
		<link>http://www.drug-attorneys.com/medical-devices/unomedical-recalls-manual-pulmonary-resuscitators-mprs-10062009</link>
		<comments>http://www.drug-attorneys.com/medical-devices/unomedical-recalls-manual-pulmonary-resuscitators-mprs-10062009#comments</comments>
		<pubDate>Tue, 06 Oct 2009 13:00:05 +0000</pubDate>
		<dc:creator>Legal Staff</dc:creator>
				<category><![CDATA[FDA Recalls]]></category>
		<category><![CDATA[Medical Devices]]></category>

		<guid isPermaLink="false">http://www.drug-attorneys.com/?p=419</guid>
		<description><![CDATA[Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: Unomedical MPR Recall. This [...]]]></description>
			<content:encoded><![CDATA[<p>Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: <a href="http://www.unomedical.com/?pageid=H3160" target="_blank">Unomedical MPR Recall</a>. This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.</p>
<p>Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.</p>
<p>In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.</p>
<p>The MPR is a single-patient use device used by healthcare professionals. It is intended for patients requiring total or intermittent ventilatory support.</p>
<p>Unomedical notified the U.S. Food &#038; Drug Administration (FDA) of its decision to voluntarily recall the product on October 1, 2009.</p>
<p>Customers with questions are urged to contact Unomedical at 1-800-634-6003. Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF- 2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at: <a href="http://www.fda.gov/medwatch/index.html" target="_blank">www.fda.gov/medwatch</a>.</p>
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