What's New Archive May 29 - Dec 31 2009

• Nzu, Traditional Remedy for Morning Sickness Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic. Posted 12/31/2009
• Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots [UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
• Thermoflect Blankets and product line - Recall FDA recommends blankets and other products not be used in MR conditional or MR compatible environments. Posted 12/28/2009
• Cleviprex (clevidipine butyrate): Recall [UPDATED] Recall of 12/2009 expanded to four additional lots. Presence of particulate matter could reduce blood flow in capillaries, cause mechanical damage to tissues, acute or chronic inflammatory reactions. [Posted 12/17/2009, Updated 03/17/2010]
• Atlas Operations, Inc.: Recall of Sexual Enhancement Products [UPDATED 04/14/2010] Recall expanded to include additional products, sold as a dietary supplements, containing undeclared sulfoaildenafil, which may result in lowering of blood pressure to dangerous levels. Originally posted 12/15/2009
• Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging One lot recalled because labeling on the foil blister card of certain packages were printed with the label reversed, and consumers may not be aware of the warnings of an antihistamine that could cause drowsiness. Posted 12/09/2009
• CT Brain Perfusion Scans Safety Investigation: Initial Notification
  [UPDATED 12/07/2009] FDA identified at least 50 additional patients exposed to excess radiation; interim recommendations for imaging facilities provided. Posted 10/09/2009
• Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes Cases of drug-induced hepatotoxicity reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Posted 12/04/2009
• Steris System 1 Processor: FDA Notice and Recommendations [UPDATED 12/17/2009] List of alternative products added. Unapproved device with potential for improper sterilization and disinfection. Posted 12/03/2009
• Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects Increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products during pregnancy. Posted 12/03/2009
• Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter Potential association between Lexiva and myocardial infarction in HIV infected adults. Posted 12/03/2009
• Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter Risk of sudden death and cardiac dysrhythmias in patients being treated with Norpramin. Posted 12/02/2009
• Stryker Operating Room System II Surgical Navigation System - Recall [UPDATED 12/10/2009] Recall classified as Class 1. A potential for the navigation PC SPC-1 component to stop working which could result in harms associated with this failure. Posted 11/27/2009
• Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo. Posted 11/20/2009
• Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use. Posted 11/19/2009
• Vicks Sinex Nasal Spray - Recall Product found containing the bacteria B. cepacia. Posted 11/19/2009
• RockHard Weekend - product contains undeclared drug ingredient Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil. Posted 11/18/2009
• Cardiovascular Systems ViperSheath Sheath Introducer - Recall [UPDATED 12/04/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use. Posted 11/17/2009
• IDS Sports Dietary Supplements - Recall Five products marketed as dietary supplements contain undeclared substances considered to be steroids. Posted 11/17/2009
• Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole. Posted 11/17/2009
• Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification UPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT. Originally posted 11/16/2009
• Pai You Guo, Marketed as Dietary Supplement - Recall Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein. Posted 11/13/2009
• Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices. Posted 11/13/2009
• Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. Posted 11/13/2009
• Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device. Posted 11/12/2009
• External Biphasic Defibrillators Energy Levels: Initial Communication 14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient. Posted 11/10/2009
• Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery. Posted 11/09/2009
• Hospira Brand Propofol and Liposyn Products - Recall Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow. Posted 11/09/2009
• Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall [UPDATED 11/06/2009] Recall classified as Class I. Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Posted 10/30/2009
• Stiff Nights - product contains undeclared drug ingredient Consumers warned that product sold as a dietary supplement contains sulfoaildenafil. Posted 11/05/2009
• Centurion Medical Products - Premie Pack and Meconium Pack - Recall Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label. Posted 11/04/2009
• Dietary Supplements Sold on Internet by Bodybuilding.com Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. Posted 11/03/2009
• Unomedical Manual Pulmonary Resuscitator - Recall
  [UPDATED 11/03/2009] Recall classified as Class I
• Byetta (exenatide) - Renal Failure Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. Posted 11/02/2009
• Cordis CROSSOVER Sheath Introducer - Recall [UPDATED 12/23/2009] Recall classified as Class I. Nationwide recall due to stretching or fracture of the sheath during use. Posted 10/30/2009
• Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use. Posted 10/27/2009
• Peramivir IV Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers. Posted 10/24/2009, UPDATED 10/30/2009
• Rituxan (rituximab) - PML Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist. Posted 10/23/2009
• Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product. Posted 10/21/2009
• September 2009
  Monthly Safety Labeling Changes - Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, PPI/Medication Guide sections of drug Prescribing Information. Posted 10/19/2009
• Medical Device Power Cords Safety Investigation: Initial Communication Reports of sparking, charring, and fires from device power cords. Posted 10/19/2009
• Tamiflu (oseltamivir) for Oral Suspension
  [UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet.
• Dexferrum (iron dextran injection) - Labeling Change Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Posted 10/16/2009
• Relenza (zanamivir) Inhalation Powder Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator. Posted 10/09/2009
• CT Brain Perfusion Scans Safety Investigation: Initial Notification Initial Notification of risk of radiation overexposures during CT brain perfusion scans. Posted 10/09/2009
• Unomedical Manual Pulmonary Resuscitator - Recall Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly. Posted 10/07/2009
• Philips Heartstart Fr2+ Automated External Defibrillators - Recall Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. Posted 10/05/2009
• Neuron 6F 070 Delivery Catheter [Penumbra] Reports that the catheter could kink or ovalize and lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Posted 10/01/2009
• Heparin: Change in Reference Standard UPDATED 04/07/2010. New studies reinforce FDA’s previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient. Originally posted 10/01/2009.
• Neocate Infant Specialized Formula - Recall Nationwide recall of Neocate Infant Specialized Formula, Lot # P91877, due to a manufacturing error that resulted in protein levels lower than that declared on the label. Posted 09/29/2009
• Tamiflu (oseltamivir) for Oral Suspension
  [UPDATED 09/25/2009] New links added. Originally posted 09/24/2009
• Children's and Infants' Tylenol Oral Suspension Products - Recall Voluntary recall because of potential manufacturing problems. Posted 09/25/2009
• Exjade (deferasirox) - Early Communication Early Communication describing an increased number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). Posted 09/25/2009
• Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis Cases of acute pancreatitis reported in patients treated with sitagliptin. Posted 09/25/2009
• Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009
• Tamiflu (oseltamivir) for Oral Suspension Risk of medication dosing errors reported. Posted 09/24/2009
• Natalizumab (marketed as Tysabri) FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Posted 09/17/2009
• Promethazine Hydrochloride Injection Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine. Posted 09/16/2009
• LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc) Class I recall due to failure or delay in delivery of therapy. Posted 09/16/2009
• Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) Nationwide recall due to risk of obstruction and inability to ventilate patient. Posted 09/11/2009
• Covidien Pedi-Cap End-Tidal CO2 Detector Class I recall because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation. Posted 09/10/2009
• ConMed Linvatec - Universal Cables and Power Pro Handpieces Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff. Posted 09/10/2009
• Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand) Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol. Posted 09/10/2009
• Penumbra Neuron 5F Select Catheter Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture. Posted 09/09/2009
• Philips Avalon Fetal Monitors Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress. Posted 09/04/2009
• Myfortic (mycophenolic acid) Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. Posted 09/03/2009
• Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009
  [UPDATED 08/31/2009] Supplemental Q&As added (increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents). Original posting 08/04/2009
• FDA Patient Safety News Video Broadcasts
  September 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 08/31/2009
• Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) [UPDATED 08/28/2009] Leukotriene inhibitors to be labeled with warnings for neuropsychiatric events. Posted 6/12/2009
• Intelence (etravirine) Reports of severe, potentially life-threatening and fatal skin reactions, including cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and hypersensitivity reactions. Posted 08/27/2009
• Levemir Insulin (Novo Nordisk) [UPDATED 08/26/2009] Stolen vials of Levemir still may be on the market. FDA received multiple reports of patients who suffered adverse events due to poor control of glucose levels after using vial from stolen lots. Posted 06/13/2009
• Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom] [UPDATED 08/25/2009] Voluntary recall classified as Class 1 due to the reasonable probability that use of these products will cause serious injury or death. Posted 07/22/2009
• Steam Dietary Supplement [UPDATED] Nationwide recall expanded, new lot added due to undeclared drug ingredient. Posted 08/24/2009
• Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review FDA is reviewing reports of serious liver injury, including liver failure. Posted 08/24/2009
• Accusure Insulin Syringes [31G, 1/2 cc and 1 cc] Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection. Posted 08/24/2009
• Ibuprofen (Unapproved) topical drug products The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. [08/21/2009]
• Hospira, Inc. Device Recall Potential risks from Hospira, Inc. devices power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Posted 08/17/2009
• Dextroamphetamine, Amphetamine 20mg Tablets Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. Posted 08/14/2009
• CellCept (mycophenolate mofetil) August 2009 Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. Posted 08/14/2009
• GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology Possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. Posted 08/13/2009
• Nuby Gel Filled, Cottontails, and Playschool Teethers Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm. Posted 07/18/2009
• July 2009
  Monthly Safety Labeling Changes - Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, PPI/Medication Guide sections of drug Prescribing Information. Posted 08/12/2009
• Alaris System (Cardinal Health) Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death. Posted 08/05/2009
• Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 FDA notified healthcare professionals of an update to the Boxed Warning describing an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers. Posted 08/04/2009
• FDA Patient Safety News Video Broadcasts
  August 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Posted 08/04/2009
• Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) [UPDATED] FDA announced changes to the established drug names to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and...
• POWERSAIL Coronary Dilatation Catheters Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction. Posted 07/30/2009
• Colchicine (marketed as Colcrys) Two previously uncharacterized safety concerns associated with the use of colchicine. Posted 07/30/2009
• Body Building Products (Marketed as Containing Steroids or Steroid-like Substances) Products are unapproved drugs and associated with serious risks of liver injury, stroke. Posted 07/28/2009
• Electronic Cigarettes FDA analysis has found carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. Posted 07/22/2009
• Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]
  Nationwide recall due to potential risk of fire and burns for patient and caregiver. Posted 07/22/2009
• Nuby Gel Filled, Cottontails, and Playschool Teethers Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm. Posted 07/18/2009
• Weight Loss Products by Young You Corporation Products recalled due to an undeclared drug ingredient which may present a significant health risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/17/2009
• Propofol Injectable Emulsion, 10 mg/mL 100 mL vials Recall due to presence of elevated endotoxin levels in some vials. Posted 07/17/2009
• Omalizumab (marketed as Xolair) - Early Communication about an Ongoing Safety Review FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events. Posted 07/16/2009
• Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac Male enhancement products recalled because samples were found to contain undeclared drug ingredients. Posted 07/16/2009
• Concentrated Acetaminophen Drops Nationwide recall of all lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops in 16 oz (473 ml) bulk containers, a cautionary measure to minimize any confusion and potential risk to patients from dosing errors. Posted 07/15/2009
• Libipower Plus Product recalled because samples were found to contain an undeclared drug ingredient. Posted 07/14/2009
• Immunosuppressant Drugs: Required Labeling Changes FDA requiring manufacturers of immunosuppressant drugs to update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy. Posted 07/14/2009
• Medtronic Paradigm Quick-Set Infusion Sets Nationwide recall because the affected infusion sets may not allow the insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin, potentially leading to serious injury or death. Posted 07/13/2009
• Mallinckrodt Sodium Chromate Cr-51 Injection Recall of product due to subpotency and possibility of misdiagnosis or delayed diagnosis. Posted 07/10/2009
• June 2009 Monthly Safety Labeling Changes -Summary of revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS,PPI/Medication Guide sections of drug Prescribing Information. Posted 07/09/2009
• BiPAP Focus Non-Invasive Ventilator System, Respironics California Class I Recall due to power supply failures that have occurred on some ventilators. Posted 07/09/2009
• Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc Nationwide recall because of the potential for contamination with Salmonella. Posted 07/09/2009
• Propoxyphene-containing Products FDA taking actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. Posted 07/07/2009
• Arthroscopic Shavers: Ongoing Safety Review Reports submitted to FDA describing instances of tissue remaining within certain arthroscopic shavers, even after the cleaning process was believed to have been completed. Posted 07/07/2009
• Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) FDA requires new Boxed Warnings and patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms. Posted 07/01/2009
• Lantus (insulin glargine) UPDATED 01/12/2011. FDA is updating the public about its ongoing safety review of Lantus and a possible increased risk of cancer. At this time, FDA has not concluded that Lantus increases the risk of cancer. Originally posted 07/01/2009
• FDA Patient Safety News Video Broadcasts
  July 2009 video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. (Posted 07/01/2009)
• FDA Drug Safety Newsletter
  Information for healthcare professionals about the findings of selected postmarketing drug safety reviews from FDA, as well as information on important emerging drug safety issues and recently approved new molecular entities. Posted 06/26/2009
• Nestle Toll House Prepackaged, Refrigerated Cookie Dough FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Posted 06/20/2009
• Stamina-Rx Dietary Supplement Products Nationwide recall due to analysis of Stamina-Rx samples found to contain undeclared ingredient benzamidenafil, a Phosphodiesterase Type 5 inhibitor. Posted 06/19/2009
• Cefepime (marketed as Maxipime) Update of Ongoing Safety Review FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Posted 06/17/2009
• Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) Reports of permanent loss of sense of smell with use of these nasal gel or swab products. Posted 06/16/2009
• Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review UPDATED 12/12/2011. Safety Review Update. Continue to prescribe drugs used for the treatment of ADHD according to the professional prescribing directions. Originally posted 06/15/2009
• Levemir Insulin (Novo Nordisk)
  Patients advised to check personal supply of insulin to identify possible stolen and dangerous product. Posted 06/13/2009
• Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) [UPDATED 08/28/2009] Leukotriene inhibitors to be labeled with warnings for neuropsychiatric events. Posted 6/12/2009
• Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Posted 06/11/2009
• Sirolimus (marketed as Rapamune) Clinical trial data suggests increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus. Posted 06/11/2009
• Skin Products Made by Clarcon Skin sanitizers and skin protectants recalled because of high levels of disease-causing bacteria found in the products. Posted 06/09/2009
• Propylthiouracil [Updated 04/21/2010] FDA added a Boxed Warning to the label,to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients.
• Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009
• Fun Express Water-based Face Paints for Children UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint) (Updated 05/26/2009)
• Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003 Class I recall issued because the monitors may fail to sound an alarm. (Posted 05/18/2009)
• Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) UPDATE - Recall due to variance in amount of active ingredient. (UPDATED 05/12/2009)
• Tarceva (erlotinib) May 2009 Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration. (Posted 05/08/2009)
• Biosite brand Triage Cardiac Panel Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. (Posted 05/08/2009)
• Testosterone gel products (AndroGel 1% and Testim 1% ) Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone. (Posted 05/07/2009)