FDA MedWatch via MedWorm.com MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'FDA MedWatch' source. Wed, 08 Feb 2012 07:07:08 +0100 Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=5666534&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm290518.htm Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5666534 Mon, 06 Feb 2012 15:00:00 +0100 5666534 Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up http://www.medworm.com/index.php?rid=5659265&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm290295.htm During packaging and labeling, tablets from one product type may have carried over into packaging of another product. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5659265 Fri, 03 Feb 2012 22:18:00 +0100 5659265 Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle http://www.medworm.com/index.php?rid=5659266&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm290219.htm Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5659266 Fri, 03 Feb 2012 15:06:00 +0100 5659266 Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets http://www.medworm.com/index.php?rid=5646778&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm289803.htm Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5646778 Wed, 01 Feb 2012 13:25:00 +0100 5646778 Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans http://www.medworm.com/index.php?rid=5646779&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm289705.htm Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5646779 Tue, 31 Jan 2012 18:10:00 +0100 5646779 Treanda (bendamustine HCL): Recall - Particulate Matter in Vial http://www.medworm.com/index.php?rid=5646780&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm289521.htm Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5646780 Mon, 30 Jan 2012 13:50:00 +0100 5646780 Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) http://www.medworm.com/index.php?rid=5619564&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm288602.htm The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5619564 Fri, 20 Jan 2012 22:30:00 +0100 5619564 Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards http://www.medworm.com/index.php?rid=5619565&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm288562.htm Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5619565 Fri, 20 Jan 2012 19:55:00 +0100 5619565 Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination http://www.medworm.com/index.php?rid=5619566&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm288432.htm Possibility of an adverse reaction or unknown drug-drug interaction. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5619566 Fri, 20 Jan 2012 18:20:00 +0100 5619566 Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity http://www.medworm.com/index.php?rid=5596755&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm287710.htm New Boxed Warning and Contraindication highlighting these risks added to product labeling. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5596755 Fri, 13 Jan 2012 17:01:00 +0100 5596755 Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient http://www.medworm.com/index.php?rid=5580714&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm287575.htm Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5580714 Thu, 12 Jan 2012 19:30:00 +0100 5580714 Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles http://www.medworm.com/index.php?rid=5580715&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm287411.htm Particulate matter in injections can be harmful when introduced into the bloodstream. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5580715 Thu, 12 Jan 2012 17:58:00 +0100 5580715 Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk http://www.medworm.com/index.php?rid=5580716&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm286280.htm A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5580716 Mon, 09 Jan 2012 15:40:00 +0100 5580716 Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps http://www.medworm.com/index.php?rid=5580717&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm286265.htm Consumers are asked to either destroy or return unused product identified in the recall to Novartis. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5580717 Mon, 09 Jan 2012 15:00:00 +0100 5580717 Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings http://www.medworm.com/index.php?rid=5571803&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm285803.htm Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5571803 Wed, 04 Jan 2012 20:18:00 +0100 5571803 CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation http://www.medworm.com/index.php?rid=5537320&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm285063.htm Ventilator may stop ventilating and result in life-threatening injury or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5537320 Fri, 23 Dec 2011 21:50:00 +0100 5537320 Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors http://www.medworm.com/index.php?rid=5537321&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm284807.htm Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5537321 Thu, 22 Dec 2011 20:25:00 +0100 5537321 Eclectic Institute Dietary Supplements: Recall - Possible Salmonella Contamination http://www.medworm.com/index.php?rid=5537322&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm284711.htm Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5537322 Thu, 22 Dec 2011 17:45:00 +0100 5537322 ShoulderFlex Massager: Warning - Risk of Strangulation http://www.medworm.com/index.php?rid=5523833&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm284510.htm Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5523833 Wed, 21 Dec 2011 19:00:00 +0100 5523833 St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation http://www.medworm.com/index.php?rid=5523834&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm284390.htm Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5523834 Wed, 21 Dec 2011 13:10:00 +0100 5523834 Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose http://www.medworm.com/index.php?rid=5523835&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm284355.htm Patients with MS should not stop taking Gilenya without talking to their healthcare professional. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5523835 Tue, 20 Dec 2011 20:15:00 +0100 5523835 Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn http://www.medworm.com/index.php?rid=5504205&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm283696.htm Conflicting results from different studies makes it premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5504205 Wed, 14 Dec 2011 21:00:00 +0100 5504205 November 2011 http://www.medworm.com/index.php?rid=5504206&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2Fucm282966.htm Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5504206 Mon, 12 Dec 2011 16:20:00 +0100 5504206 Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events http://www.medworm.com/index.php?rid=5486233&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm282820.htm Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. FDA is working to determine whether reports of bleeding are occurring more commonly than would be expected. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5486233 Wed, 07 Dec 2011 18:20:00 +0100 5486233 CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall - Unintended Residue on Lenses http://www.medworm.com/index.php?rid=5486234&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm282756.htm Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5486234 Wed, 07 Dec 2011 17:05:00 +0100 5486234 CooperVision AVAIRA Toric and Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses http://www.medworm.com/index.php?rid=5486235&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm275876.htm UPDATED 11/18/2011. Expansion of recall. Presence of a silicone oil residue on lenses from certain lots may cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5486235 Fri, 18 Nov 2011 20:30:00 +0100 5486235 October 2011 http://www.medworm.com/index.php?rid=5449473&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2Fucm279222.htm Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5449473 Fri, 18 Nov 2011 20:00:00 +0100 5449473 Virility Max: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=5406793&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm279698.htm Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5406793 Mon, 14 Nov 2011 15:40:00 +0100 5406793 Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury http://www.medworm.com/index.php?rid=5399910&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm279266.htm Potential for patient falls or unanticipated patient movement, which may result in serious injury or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5399910 Wed, 09 Nov 2011 19:50:00 +0100 5399910 Trilipix (fenofibric acid): Drug Safety Communication - Label Change http://www.medworm.com/index.php?rid=5399911&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm279185.htm The ACCORD Lipid trial found no significant difference in the risk of a major adverse cardiac event between group treated with fenofibrate plus simvastatin compared with simvastatin alone. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5399911 Wed, 09 Nov 2011 15:00:00 +0100 5399911 CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation http://www.medworm.com/index.php?rid=5383058&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm278677.htm Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5383058 Fri, 04 Nov 2011 18:30:00 +0100 5383058 Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit http://www.medworm.com/index.php?rid=5346679&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm277143.htm In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5346679 Tue, 25 Oct 2011 15:40:00 +0100 5346679 Chantix (varenicline) http://www.medworm.com/index.php?rid=5346680&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm079818.htm UPDATED 10/24/2011. Updated study data. Healthcare professionals should continue to monitor patients for neuropsychiatric symptoms. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5346680 Mon, 24 Oct 2011 16:10:00 +0100 5346680 Nostrilla Nasal Decongestant: Recall - Bacterial Contamination http://www.medworm.com/index.php?rid=5334845&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm276771.htm Burkholderia cepacia bacteria may cause serious infection in individuals with a compromised immune system or chronic lung condition. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5334845 Fri, 21 Oct 2011 15:00:00 +0100 5334845 CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses http://www.medworm.com/index.php?rid=5313674&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm275876.htm Presence of a silicone oil residue on lenses from certain lots of my cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5313674 Fri, 14 Oct 2011 22:50:00 +0100 5313674 Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension http://www.medworm.com/index.php?rid=5303914&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm275176.htm Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel, as well as during treatment. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5303914 Tue, 11 Oct 2011 13:30:00 +0100 5303914 Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid http://www.medworm.com/index.php?rid=5296399&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm274746.htm Product marketed as testosterone booster contains superdrol, a synthetic steroid. Use of synthetic anabolic steroids may cause serious long-term adverse health consequences. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5296399 Thu, 06 Oct 2011 19:55:00 +0100 5296399 Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error http://www.medworm.com/index.php?rid=5224158&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm272237.htm Daily regimen may be incorrect and could leave women without adequate contraception. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5224158 Fri, 16 Sep 2011 18:50:00 +0100 5224158 Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms http://www.medworm.com/index.php?rid=5224159&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm272041.htm Avoid use of ondansetron in patients with congenital long QT syndrome, and monitor those with electrolyte abnormalities, CHF, bradyarrhythmias, or those taking concomitant medications that prolong the QT interval. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5224159 Thu, 15 Sep 2011 19:00:00 +0100 5224159 August 2011 http://www.medworm.com/index.php?rid=5236593&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2Fucm268289.htm Safety Labeling Changes with revisions to Prescribing Information (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5236593 Thu, 15 Sep 2011 15:00:00 +0100 5236593 Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance http://www.medworm.com/index.php?rid=5224160&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm271510.htm Potential for reduced battery performance can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5224160 Mon, 12 Sep 2011 18:20:00 +0100 5224160 Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria http://www.medworm.com/index.php?rid=5207487&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm270977.htm Patients treated with TNFα blockers are at increased risk for developing serious infections. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5207487 Wed, 07 Sep 2011 18:00:00 +0100 5207487 Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions http://www.medworm.com/index.php?rid=5183056&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm270600.htm Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5183056 Thu, 01 Sep 2011 20:00:00 +0100 5183056 Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment http://www.medworm.com/index.php?rid=5183057&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm270464.htm Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5183057 Thu, 01 Sep 2011 15:00:00 +0100 5183057 H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing http://www.medworm.com/index.php?rid=5160721&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm269800.htm High risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5160721 Fri, 26 Aug 2011 15:35:00 +0100 5160721 ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation http://www.medworm.com/index.php?rid=5160722&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm269765.htm Hair, clothing, and jewelry can become entangled in the massage device and cause serious injury or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5160722 Fri, 26 Aug 2011 14:50:00 +0100 5160722 Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses http://www.medworm.com/index.php?rid=5160723&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm269481.htm Citalopram should no longer be prescribed at doses greater than 40 mg per day. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5160723 Wed, 24 Aug 2011 13:46:00 +0100 5160723 Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency http://www.medworm.com/index.php?rid=5096012&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm266648.htm Some vials may not maintain potency throughout their shelf-life, which may lead to reduced effectiveness. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5096012 Thu, 04 Aug 2011 12:35:00 +0100 5096012 GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall http://www.medworm.com/index.php?rid=5096013&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm266580.htm HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5096013 Wed, 03 Aug 2011 19:20:00 +0100 5096013 Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall http://www.medworm.com/index.php?rid=5096015&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm266526.htm Reports of breakage and/or separation of the stylet. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5096015 Wed, 03 Aug 2011 17:00:00 +0100 5096015 Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects http://www.medworm.com/index.php?rid=5096016&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm266468.htm Pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5096016 Wed, 03 Aug 2011 15:00:00 +0100 5096016 GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Innaccurate Results http://www.medworm.com/index.php?rid=5086881&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm266113.htm Potassium test results too low when compared to a reference analyzer, which may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5086881 Mon, 01 Aug 2011 14:00:00 +0100 5086881 Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall - Biohazardous Materials May be Released http://www.medworm.com/index.php?rid=5069629&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm265707.htm Potential for Centrifuge bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge, which may result in serious personal injury and damage to the surrounding area. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5069629 Wed, 27 Jul 2011 18:16:00 +0100 5069629 Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications http://www.medworm.com/index.php?rid=5069630&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm265476.htm Symptoms may include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5069630 Tue, 26 Jul 2011 18:02:00 +0100 5069630 Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications http://www.medworm.com/index.php?rid=5069631&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm265479.htm Symptoms may include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5069631 Tue, 26 Jul 2011 18:01:00 +0100 5069631 Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events http://www.medworm.com/index.php?rid=5052164&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm264204.htm FDA reviewing data from a clinical trial. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5052164 Fri, 22 Jul 2011 02:10:00 +0100 5052164 Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer http://www.medworm.com/index.php?rid=5052165&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm264087.htm FDA is reviewing data from published studies to evaluate risk of cancer of the esophagus. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5052165 Thu, 21 Jul 2011 16:50:00 +0100 5052165 CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure http://www.medworm.com/index.php?rid=5037761&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm263157.htm Potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5037761 Fri, 15 Jul 2011 14:00:00 +0100 5037761 June 2011 http://www.medworm.com/index.php?rid=5052166&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2Fucm261325.htm Monthly Safety Labeling Changes includes 50 products with revisions to Prescribing Information. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5052166 Fri, 15 Jul 2011 04:00:00 +0100 5052166 Transvaginal Placement of Surgical Mesh http://www.medworm.com/index.php?rid=5029886&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm079028.htm Warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5029886 Wed, 13 Jul 2011 04:00:00 +0100 5029886 Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL) http://www.medworm.com/index.php?rid=5019815&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm262432.htm Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5019815 Mon, 11 Jul 2011 13:45:00 +0100 5019815 Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules: Public Notification - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=5009353&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm262387.htm Products marketed as dietary supplements contain sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5009353 Fri, 08 Jul 2011 19:30:00 +0100 5009353 Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=5009354&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm262376.htm Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5009354 Fri, 08 Jul 2011 19:20:00 +0100 5009354 Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS) http://www.medworm.com/index.php?rid=5009355&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm262210.htm Increased Risk of Post-transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML). (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=5009355 Thu, 07 Jul 2011 19:20:00 +0100 5009355 Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy) http://www.medworm.com/index.php?rid=4985348&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm261610.htm Benefits and risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4985348 Thu, 30 Jun 2011 18:40:00 +0100 4985348 Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor http://www.medworm.com/index.php?rid=4985349&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm261509.htm One lot recalled due to the presence of trace amounts of a 2,4,6-tribromoanisole (TBA), which has been associated with temporary and non-serious gastrointestinal symptoms. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4985349 Thu, 30 Jun 2011 02:30:00 +0100 4985349 Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets http://www.medworm.com/index.php?rid=4977162&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm260979.htm Risk of increase of acetaminophen dose, which may result in liver toxicity, especially in patients on other acetaminophen containing medications. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4977162 Mon, 27 Jun 2011 16:44:00 +0100 4977162 Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled http://www.medworm.com/index.php?rid=4977163&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm260915.htm Recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4977163 Mon, 27 Jun 2011 16:07:00 +0100 4977163 Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations http://www.medworm.com/index.php?rid=4969669&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm260641.htm Increased risks of cardiovascular events using ESAs in this patient population. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4969669 Fri, 24 Jun 2011 15:30:00 +0100 4969669 Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor http://www.medworm.com/index.php?rid=4954021&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259901.htm Two lots recalled. Contamination thought to be the result of a chemical preservative applied to wood used in the construction of pallets on which materials are transported and stored. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4954021 Mon, 20 Jun 2011 17:16:00 +0100 4954021 Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy http://www.medworm.com/index.php?rid=4935939&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259764.htm Failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935939 Fri, 17 Jun 2011 18:10:00 +0100 4935939 Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events http://www.medworm.com/index.php?rid=4935940&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259469.htm Results of a randomized, double-blind, placebo-controlled clinical trial of 700 smokers reviewed. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935940 Thu, 16 Jun 2011 19:15:00 +0100 4935940 Indomethacin for Injection: Recall of One Lot - Particulate Matter http://www.medworm.com/index.php?rid=4935941&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259262.htm Particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935941 Wed, 15 Jun 2011 18:00:00 +0100 4935941 Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient http://www.medworm.com/index.php?rid=4935942&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259097.htm Risk of embolization causing tissue and blood vessel injury, heart attack or other serious events. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935942 Tue, 14 Jun 2011 18:10:00 +0100 4935942 Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize http://www.medworm.com/index.php?rid=4935943&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259082.htm Risk of arterial injury, hemorrhaging, or other serious events. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935943 Tue, 14 Jun 2011 16:55:00 +0100 4935943 Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning http://www.medworm.com/index.php?rid=4935944&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm259078.htm Consequences may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935944 Tue, 14 Jun 2011 16:45:00 +0100 4935944 Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion http://www.medworm.com/index.php?rid=4935945&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm258905.htm Healthcare Professionals reminded to clearly print or spell out the medication name on prescriptions. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935945 Mon, 13 Jun 2011 18:40:00 +0100 4935945 Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis http://www.medworm.com/index.php?rid=4935946&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm258826.htm Reminder: Victoza not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4935946 Mon, 13 Jun 2011 15:16:00 +0100 4935946 5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer http://www.medworm.com/index.php?rid=4912949&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm258529.htm Two large, randomized controlled trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4912949 Thu, 09 Jun 2011 17:58:00 +0100 4912949 Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations http://www.medworm.com/index.php?rid=4912950&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm258384.htm Patients taking simvastatin 80 mg daily have an increased risk of myopathy, including rhabdomyolysis, which can damage the kidneys and lead to kidney failure which can be fatal. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4912950 Wed, 08 Jun 2011 22:35:00 +0100 4912950 Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4912951&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm258161.htm Product contains analogs of Sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4912951 Tue, 07 Jun 2011 14:35:00 +0100 4912951 Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient http://www.medworm.com/index.php?rid=4903510&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm258133.htm Inhalation of the plastic strands may cause respiratory compromise, which could result in serious illness or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4903510 Tue, 07 Jun 2011 13:30:00 +0100 4903510 Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products http://www.medworm.com/index.php?rid=4894544&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm257723.htm Potential for serious anaphylactic reaction in patients with known hypersensitivity to beta-lactam or penicillin products. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4894544 Fri, 03 Jun 2011 17:45:00 +0100 4894544 Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication http://www.medworm.com/index.php?rid=4894545&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm257707.htm Thermography is not a replacement for screening mammography and should not be used by itself to diagnose breast cancer. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4894545 Thu, 02 Jun 2011 21:50:00 +0100 4894545 Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed http://www.medworm.com/index.php?rid=4894546&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm219185.htm No increase in risk of cancer with ARB blood pressure drugs. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4894546 Thu, 02 Jun 2011 21:15:00 +0100 4894546 Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots http://www.medworm.com/index.php?rid=4884514&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm257337.htm Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4884514 Tue, 31 May 2011 18:00:00 +0100 4884514 Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results http://www.medworm.com/index.php?rid=4853870&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm256424.htm Errors may be the result of ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, and instrument maintenance. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4853870 Mon, 23 May 2011 19:00:00 +0100 4853870 Pentrexyl Forte Natural: Recall - Misleading Packaging http://www.medworm.com/index.php?rid=4853871&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm256407.htm Dietary supplement product packaging may cause it to be confused with an antibiotic product. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4853871 Mon, 23 May 2011 18:00:00 +0100 4853871 SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition http://www.medworm.com/index.php?rid=4848360&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm256257.htm Feeding this product to infants may result in necrotizing enterocolitis, a life-threatening condition resulting in necrosis of intestinal tissue. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4848360 Fri, 20 May 2011 21:50:00 +0100 4848360 Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4805285&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm254945.htm Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4805285 Wed, 11 May 2011 13:10:00 +0100 4805285 Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock http://www.medworm.com/index.php?rid=4805286&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm254929.htm Defect may result in failure to resuscitate the patient. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4805286 Wed, 11 May 2011 12:00:00 +0100 4805286 Multi-Mex Distributor Inc. Dietary Supplements: Recall - Product Packaging Mimics OTC Antibiotics http://www.medworm.com/index.php?rid=4805287&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm254708.htm FDA inspection revealed products mimic antibiotics readily available in Mexico and possibly familiar to Hispanic consumers. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4805287 Tue, 10 May 2011 13:00:00 +0100 4805287 Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy http://www.medworm.com/index.php?rid=4795115&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm254363.htm Clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4795115 Fri, 06 May 2011 14:00:00 +0100 4795115 Boston Scientific Devices Stolen – Risk of Infection http://www.medworm.com/index.php?rid=4781775&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm253937.htm Labels on these devices state that they are “Sterile”; however, they were stolen prior to being sterilized and are non-sterile. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4781775 Wed, 04 May 2011 12:00:00 +0100 4781775 Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency http://www.medworm.com/index.php?rid=4781776&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm253615.htm Increased risk of bleeding if there is too much active ingredient in tablet. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4781776 Tue, 03 May 2011 14:25:00 +0100 4781776 Regenerect: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4776119&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm253416.htm Product marketed as dietary supplement contain drug ingredient sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4776119 Mon, 02 May 2011 16:13:00 +0100 4776119 Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes http://www.medworm.com/index.php?rid=4720138&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm251575.htm Tablets may not fully disintegrate when water is added, and/or they may disintegrate but later form clumps which can adhere to the inside walls of oral syringes and feeding tubes. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4720138 Fri, 15 Apr 2011 14:00:00 +0100 4720138 Topamax (topiramate): Recall - Musty Odor http://www.medworm.com/index.php?rid=4715127&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm251556.htm Two lots of topiramate 100mg tablets recalled, reports of temporary gastrointestinal symptoms. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4715127 Fri, 15 Apr 2011 12:00:00 +0100 4715127 Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults http://www.medworm.com/index.php?rid=4715128&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm251443.htm FDA continues to receive reports of a rare cancer of white blood cells. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4715128 Thu, 14 Apr 2011 14:50:00 +0100 4715128 Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil http://www.medworm.com/index.php?rid=4709649&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm251402.htm Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4709649 Wed, 13 Apr 2011 22:30:00 +0100 4709649 Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten http://www.medworm.com/index.php?rid=4709650&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm251353.htm After use for IORT in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4709650 Wed, 13 Apr 2011 21:20:00 +0100 4709650 Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies http://www.medworm.com/index.php?rid=4693683&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm250606.htm Patients may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4693683 Sat, 09 Apr 2011 02:15:00 +0100 4693683 Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia http://www.medworm.com/index.php?rid=4685519&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm250264.htm FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4685519 Thu, 07 Apr 2011 13:00:00 +0100 4685519 Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions http://www.medworm.com/index.php?rid=4685520&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm249770.htm The most common severe reactions include enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4685520 Wed, 06 Apr 2011 15:00:00 +0100 4685520 Best Enhancer: Recall – Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4677335&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm249749.htm Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4677335 Tue, 05 Apr 2011 12:15:00 +0100 4677335 Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient Adhesive http://www.medworm.com/index.php?rid=4664274&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm249395.htm The deployment tube may detach during use and may result in the failure of the product to operate, This may cause serious injury and/or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4664274 Fri, 01 Apr 2011 11:32:00 +0100 4664274 Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall http://www.medworm.com/index.php?rid=4664275&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm249387.htm Small particles (debris) may be found inside the catheter and potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs which can result in serious injury and /or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4664275 Fri, 01 Apr 2011 10:50:00 +0100 4664275 Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals http://www.medworm.com/index.php?rid=4658961&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm249099.htm Use of contaminated products may lead to bacterial infection of the blood. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4658961 Wed, 30 Mar 2011 18:43:00 +0100 4658961 Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements http://www.medworm.com/index.php?rid=4654011&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm249005.htm Potential for product breakdown and loss of potency if not dispensed and stored in the original bottle or blister package. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4654011 Wed, 30 Mar 2011 12:40:00 +0100 4654011 X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4654012&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248814.htm Products marketed as dietary supplement contain drug ingredients sulfosildenafil or tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4654012 Tue, 29 Mar 2011 14:25:00 +0100 4654012 Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin http://www.medworm.com/index.php?rid=4643713&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248784.htm Use of recalled product can result in elevated blood glucose levels (hyperglycemia), which can lead to serious health complications including death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4643713 Tue, 29 Mar 2011 13:25:00 +0100 4643713 Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and D http://www.medworm.com/index.php?rid=4643714&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248738.htm Reports of consumers experiencing decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4643714 Tue, 29 Mar 2011 11:55:00 +0100 4643714 Celerite Slimming Tea: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4643715&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248610.htm Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4643715 Mon, 28 Mar 2011 14:20:00 +0100 4643715 Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant http://www.medworm.com/index.php?rid=4643716&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248598.htm Non-sterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections which could be fatal, especially in patients who are immunocompromised. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4643716 Mon, 28 Mar 2011 13:35:00 +0100 4643716 Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling http://www.medworm.com/index.php?rid=4643717&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248595.htm Bottles labeled as citalopram may contain finasteride. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4643717 Mon, 28 Mar 2011 13:15:00 +0100 4643717 U-Prosta: Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4632151&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm248293.htm Product marketed as dietary supplement contains terazosin, adverse health consequences that could occur with the use of this product would be hypotension, dizziness, or syncope. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4632151 Thu, 24 Mar 2011 13:08:00 +0100 4632151 H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination http://www.medworm.com/index.php?rid=4671225&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm247743.htm Use of contaminated Povidone Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4671225 Fri, 18 Mar 2011 19:40:00 +0100 4671225 H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination http://www.medworm.com/index.php?rid=4616277&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm247743.htm Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4616277 Fri, 18 Mar 2011 19:40:00 +0100 4616277 Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test: Class I Recall http://www.medworm.com/index.php?rid=4606516&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm247569.htm Possible false-negative results may occur. This may cause serious adverse consequences and/or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4606516 Thu, 17 Mar 2011 19:55:00 +0100 4606516 Black Ant: Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4601203&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm247434.htm Product marketed as dietary supplement contains Sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4601203 Wed, 16 Mar 2011 20:05:00 +0100 4601203 Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies http://www.medworm.com/index.php?rid=4561270&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm246167.htm New Warning about serious heart, kidney, or breathing problems which can be fatal. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4561270 Tue, 08 Mar 2011 15:55:00 +0100 4561270 Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns http://www.medworm.com/index.php?rid=4550114&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm245777.htm Increased risk of oral clefts in infants born to women treated with Topamax (topiramate) during pregnancy. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4550114 Fri, 04 Mar 2011 16:35:00 +0100 4550114 Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels http://www.medworm.com/index.php?rid=4550115&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm245720.htm Endotoxins in product can cause serious illness, at times fatal. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4550115 Fri, 04 Mar 2011 14:50:00 +0100 4550115 Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays: Class I Recall - Leaks in Plunger Luer Detected http://www.medworm.com/index.php?rid=4545391&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm245634.htm Leakage and possible loss of sterility, which may lead to serious adverse health consequences and/or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4545391 Thu, 03 Mar 2011 22:10:00 +0100 4545391 Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market http://www.medworm.com/index.php?rid=4541138&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm245279.htm Unapproved products have not been evaluated by the FDA for safety, effectiveness, and quality. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4541138 Wed, 02 Mar 2011 15:10:00 +0100 4541138 Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use http://www.medworm.com/index.php?rid=4536115&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm245275.htm Prolonged treatment with prescription PPIs may lead to low serum magnesium levels, which can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures). (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4536115 Wed, 02 Mar 2011 15:00:00 +0100 4536115 Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack http://www.medworm.com/index.php?rid=4536116&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm245190.htm FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4536116 Tue, 01 Mar 2011 18:26:00 +0100 4536116 Svelte 30: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4522611&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm244650.htm Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4522611 Fri, 25 Feb 2011 20:00:00 +0100 4522611 Extenze Tablets: Recall http://www.medworm.com/index.php?rid=4513075&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm244369.htm Counterfeit dietary supplement contains tadalafil, sildenafil, and/or sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4513075 Wed, 23 Feb 2011 19:54:00 +0100 4513075 Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns http://www.medworm.com/index.php?rid=4507987&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm244175.htm Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4507987 Tue, 22 Feb 2011 15:50:00 +0100 4507987 Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage http://www.medworm.com/index.php?rid=4490453&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm243850.htm 10mg strength tablets found in bottle labeled as 3 mg. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4490453 Thu, 17 Feb 2011 20:00:00 +0100 4490453 Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor http://www.medworm.com/index.php?rid=4490454&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm243843.htm Potential for serious maternal heart problems and death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4490454 Thu, 17 Feb 2011 18:00:00 +0100 4490454 Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall http://www.medworm.com/index.php?rid=4483914&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm243686.htm Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4483914 Wed, 16 Feb 2011 22:19:00 +0100 4483914 Triad Sterile Lubricating Jelly: Recall - Product May Not Be Sterile http://www.medworm.com/index.php?rid=4483915&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm243552.htm Patients who are immuno-compromised may be at potential risk for infection. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4483915 Wed, 16 Feb 2011 15:30:00 +0100 4483915 Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate http://www.medworm.com/index.php?rid=4455933&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm242811.htm Use of recalled product may lead to patient harm. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4455933 Wed, 09 Feb 2011 18:40:00 +0100 4455933 Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling http://www.medworm.com/index.php?rid=4446501&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm242527.htm Patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital, which can lead to serious adverse events. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4446501 Mon, 07 Feb 2011 18:24:00 +0100 4446501 American Regent Injectable Products: Recall - Visible Particulates in Products http://www.medworm.com/index.php?rid=4439640&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm242365.htm Some vials exhibit translucent visible particles consistent with glass delamination. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4439640 Sat, 05 Feb 2011 15:20:00 +0100 4439640 Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use http://www.medworm.com/index.php?rid=4436984&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm242343.htm Use of recalled product may lead to arterial injury, hemorrhaging, blood clots (thrombosis), or other serious events. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4436984 Fri, 04 Feb 2011 21:55:00 +0100 4436984 B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive http://www.medworm.com/index.php?rid=4424827&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm241637.htm Software update may cause normal operation to stop with no visual warning signal. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4424827 Tue, 01 Feb 2011 13:55:00 +0100 4424827 Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer http://www.medworm.com/index.php?rid=4400427&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm241101.htm Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4400427 Wed, 26 Jan 2011 16:10:00 +0100 4400427 Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor: Class I Recall - Potential for Kinking of Arterial Line http://www.medworm.com/index.php?rid=4383292&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm240588.htm Kinking can cause the destruction of red blood cells which may result in serious injury and/or death. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4383292 Fri, 21 Jan 2011 15:50:00 +0100 4383292 Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury http://www.medworm.com/index.php?rid=4350127&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm240110.htm Reports include two cases of liver failure leading to liver transplant (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4350127 Fri, 14 Jan 2011 05:00:00 +0100 4350127 Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication http://www.medworm.com/index.php?rid=4343964&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm239955.htm New labeling changes to emphasize the potential for severe liver failure and serious allergic reactions (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4343964 Thu, 13 Jan 2011 17:10:00 +0100 4343964 Celerite Slimming Capsules: Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4343965&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm239915.htm Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4343965 Thu, 13 Jan 2011 15:00:00 +0100 4343965 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose http://www.medworm.com/index.php?rid=4331939&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm239559.htm Morphine sulfate oral solution ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4331939 Mon, 10 Jan 2011 20:39:00 +0100 4331939 Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination http://www.medworm.com/index.php?rid=4319071&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm239319.htm Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4319071 Thu, 06 Jan 2011 21:15:00 +0100 4319071 Metronidazole Tablets, 250mg: Recall - Underweight Tablets http://www.medworm.com/index.php?rid=4319072&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm239312.htm Underweight tablets may not contain the full amount of active ingredient within a single tablet. A consumer may not receive the prescribed dose, which may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4319072 Thu, 06 Jan 2011 21:00:00 +0100 4319072 AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall http://www.medworm.com/index.php?rid=4314640&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm239029.htm Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death or need for additional surgical intervention. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4314640 Wed, 05 Jan 2011 16:45:00 +0100 4314640 Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials http://www.medworm.com/index.php?rid=4305208&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm238624.htm Potenial for dosing error leading to albuterol toxicity. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4305208 Mon, 03 Jan 2011 20:20:00 +0100 4305208 Rock Hard Extreme and Passion Coffee by Drive Total Energy: Recall - Undeclared Drug Ingredient http://www.medworm.com/index.php?rid=4305209&cid=s_34122_4_f&fid=34122&url=http%3A%2F%2Fwww.fda.gov%2FSafety%2FMedWatch%2FSafetyInformation%2FSafetyAlertsforHumanMedicalProducts%2Fucm238537.htm Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. (Source: FDA MedWatch) FDA MedWatch news http://www.medworm.com/rss/comments.php?id=4305209 Mon, 03 Jan 2011 18:15:00 +0100 4305209