What's New Archive, Jan 01- Dec 31 2010

• Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath UPDATED 01/27/2011. Additional model & lot numbers added. Arrow Intra-Aortic Balloon (IAB) Catheter Products can become stuck in the sheath and potential to cause delay in therapy, bleeding or arterial injury. Originally posted 12/29/2010
• Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials Nationwide recall initiated December 23 due to some vials of these lots contain particulates. Posted 12/29/2010
• ev3 NanoCross .014" OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking Posted 12/28/2010
• Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product Nationwide recall initiated December 20 due to particulates or potential to form particulates in product. Posted 12/24/2010
• Lipitor (atorvastatin) 40 mg: Recall Specific Bottles UPDATED 12/23/2010. Pfizer announced a recall of one lot - 19,000 bottles — of Lipitor distributed in the U.S. Originally posted 10/10/2010
• RockHard Weekend, Pandora: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 12/23/2010
• Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death UPDATED 08/04/2011. Evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. Originally posted 12/22/2010
• Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results UPDATED 02/15/2011. Recall classified as Class I. Falsely low blood glucose results can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. Posted 12/22/2010
• Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall Use of the recalled product has led to removal of greater amounts of red blood cells than intended, resulting in hemodilution. Posted 12/21/2010
• Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms Injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in pediatric and adult patients. Posted 12/17/2010
• Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun FDA recommending removing the breast cancer indication for Avastin because the drug has not been shown to be safe and effective for that use. Posted 12/16/2010
• Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children Benzonatate drug label being revised to warn about accidental ingestion, resulting in overdose and death, in children below age 10 years. Posted 12/14/2010
• Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in Products Reports of foreign materials in the product, including metal and wood particles. Posted 12/14/2010
• Man Up Now Capsules: Consumer Warning - Undeclared Drug Ingredient Product marketed as dietary supplement contains undeclared Sulfoaidenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 12/13/2010
• Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets Cold decongestant tablets (containing Acetaminophen, Phenylephrine, and Chlorpheniramine Maleate) were mislabeled as containing only Guaifenesin tablets. Posted 12/13/2010
• November 2010 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 12/08/2010
• Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error Mid-shaft joint failures occuring in some catheters. Posted 12/08/2010
• Baxter Colleague Infusion Pumps: FDA Ordering Recall UPDATED 12/01/2010. Recall classified as Class I. Action based on failure to correct serious problems with infusion pumps. Originally posted 05/04/2010
• B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag The particles in the solution can potentially enter a patient’s body and lead to serious adverse health consequences. Posted 11/30/2010
• Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem UPDATED 11/29/2010. Recall classified as Class I. Recalled pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication. Originally posted 11/08/2010
• HiRes 90K Cochlear Implant Device: Recall - Malfunction Two confirmed instances where the product experienced a malfunction, recipients experienced severe pain, overly loud sounds and/or shocking sensations. Posted 11/27/2010
• Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall-Weak or Open Seals These medical products could become or have been contaminated due to compromise in sterility and can cause serious adverse health consequences and/or death. Posted 11/23/2010
• Vigor-25: Undeclared Drug Ingredient-Sold as natural dietary supplement Product makes claims to enhance male sexual performance and contains undeclared drug that can dangerously lower blood pressure. Posted 11/19/2010
• Propoxyphene: Withdrawal - Risk of Cardiac Toxicity New data shows that Propoxyphene and Propoxyphene-containing products can cause serious toxicity to the heart, even when used at therapeutic doses. Posted 11/19/2010
• Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems UPDATED 05/06/2011. Syringes may malfunction, break, or become clogged during the process of attempting to connect to some needleless IV access systems. Originally posted 11/18/2010
• Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion UPDATED 06/15/2012. Expanded Class I Recall issued. Risk of over-infusion, could result in serious injury or death. Originally posted 11/14/2010
• October 2010 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 11/12/2010
• VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed UPDATED 05/03/2011. Expanded Recall. Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death. Originally posted 11/10/2010
• Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains undeclared Sulfoaidenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 11/05/2010
• Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified UPDATED 11/05/2010. Consumers encouraged to return any product in their possession from the October 2010 recall. Originally posted 10/22/2010
• Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures Infusers may cease operation and exhibit an audible and visual alarm. Delay or interruption of infusion therapy may result in serious injury or death. Posted 11/04/2010
• Octopus Nuvo Tissue Stabilizer: Class I Recall - Potential for Device Fracture Fragments of the device could fall into the patient’s chest cavity and damage the heart tissue. Posted 11/01/2010
• Heparin Sodium (B. Braun): Recall - Trace Contaminant Oversulfated chondroitin sulfate (OSCS) contaminant found during sample testing. Posted 10/29/2010
• Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates Potential to develop adverse reactions in areas where the particles lodge, which could result in serious adverse events, disability, or death. Posted 10/29/2010
• Hyland’s Teething Tablets: Recall - Risk of Harm to Children FDA laboratory analysis found product to contain inconsistent amounts of belladonna, which can cause harm at larger doses. Posted 10/23/2010
• Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm Prolonged QT or PR intervals reported when Invirase is used with the antiviral medication, Norvir (ritonavir). Posted 10/21/2010
• September 2010 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 10/20/2010
• GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update) New information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. Posted 10/20/2010
• Tylenol 8 Hour Caplets 50 Count: Recall Uncharacteristic musty or moldy odor. Posted 10/19/2010
• Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death. Posted 10/15/2010
• CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy Hardware communication error may lead to serious injury or death. Posted 10/15/2010
• Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning Consumers advised to avoid OTC chelation products because of the potential for serious harm associated with their use, including dehydration, kidney failure, and death. Posted 10/14/2010
• Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update Risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. Posted 10/13/2010
• Huber Needles: Recall - Risk of Coring UPDATED 10/12/2010. Multi-Med expanded its previous recall to include all Huber needles and finished products containing Huber needles distributed from July 12, 2005 to May 28, 2010. Originally posted 08/26/2010
• Lipitor (atorvastatin) 40 mg: Recall Specific Bottles UPDATED 12/23/2010. Pfizer announced a recall of one lot - 19,000 bottles — of Lipitor distributed in the U.S. Originally posted 10/10/2010
• Slimming Beauty Bitter Orange Slimming Capsules: Undeclared Drug Ingredient Product marketed as a dietary supplement contains sibutramine, which can lead to elevated blood pressure, stroke, or heart attack. Posted 10/08/2010
• Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events Action based on data from clinical trial showing 16% increased risk of serious heart events. Posted 10/08/2010
• Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall UPDATED 10/08/2010. Serious adverse events, especially for consumers with liver, kidney, adrenal, or prostate abnormalities, associated with the use of aromatase inhibitors. Originally posted 09/20/2010
• Infant Sleep Positioners: Consumer Warning - Risk of Suffocation FDA and Consumer Product Safety Commission have received 12 reports of babies known to have died from suffocation associated with sleep positioners. Posted 09/29/2010
• Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events UPDATED 09/24/2010. Market withdrawal of all lots of product until root cause of previously reported thromboembolic events can be determined and corrected. Originally posted 08/25/2010
• Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials Recall due to risks of embolic, thrombotic and other vascular serious adverse events. Posted 09/24/2010
• Similac Powder Infant Formulas: Recall UPDATE 09/24/2010. FDA has created a searchable database to find lot numbers of affected products. Originally posted 09/23/2010
• Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns Device overheating may result in serious 1st to 3rd degree patient burns. Posted 09/24/2010
• Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events UPDATED 05/18/2011. New restrictions to the prescribing and use of rosiglitazone-containing medicines, including Avandia, Avandamet, and Avandaryl. Originally posted 09/23/2010
• Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer UPDATED 08/04/2011. Updated drug labels for pioglitazone-containing medicines, should not be used in patients with active bladder cancer. Originally posted 09/17/2010
• BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall Select lots have a potential for disconnection at the retention ring of the patient port manifold which could result in treatment delays. 09/15/2010
• August 2010 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 09/15/2010
• Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients New dosing recommendations to prevent potential overdose in pediatric transplant patients Posted 09/15/2010
• Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall Potential for the device to fail to detect air in line at the end of an infusion. Posted 09/10/2010
• Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis New recommendations in labeling for screening for renal disease prior to use and monitoring for the development of NSF. Posted 09/09/2010
• AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation Fragments of the catheter may become lodged in coronary arteries, resulting in serious injury or death. Posted 09/08/2010
• Tygacil (tigecycline): Label Change - Increased Mortality Risk Healthcare professionals should consider alternatives to Tygacil in patients with severe infections. Posted 09/01/2010
• Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices. Posted 08/26/2010
• TimeOut Capsules: Undeclared Drug Ingredient Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil, a chemical similar to sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 08/25/2010
• MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient UPDATED 08/25/2010. Product marketed as dietary supplement contains undeclared Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Originally posted 03/30/2010
• Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events UPDATED 09/24/2010. Market withdrawal of all lots of product until root cause of previously reported thromboembolic events can be determined and corrected. Originally posted 08/25/2010
• Mr. Magic Male Enhancer: Undeclared Drug Ingredient Product marketed as dietary supplement contains undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 08/24/2010
• INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients. Posted 08/23/2010
• Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk FDA evaluating clinical trial data that suggest patients taking drug may be at increased risk for cardiovascular events compared to those taking carbidopa/levodopa. Posted 08/20/2010
• Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug Companies failed to provide evidence of clinical benefit of midodrine hydrochloride because required post-approval studies that verify the clinical benefit of the drug have not been done. Posted 08/16/2010
• 6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub Potentially life threatening episode of bleeding could occur during surgical procedures. Posted 08/13/2010
• Prolatis’: Undeclared Drug Ingredient Product marketed as dietary supplement contains undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 08/13/2010
• Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis. Posted 08/12/2010
• Novacare LLC Products: Recall - Undeclared Drug Ingredient Products marketed as dietary supplement sexual enhancers for men contain undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Posted...
• Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product Suspected counterfeit product is weaker, and breaks or bends before necessary force can be applied to stop blood flow. Excessive blood loss can endanger the victim’s life and ultimately lead to death. Posted 08/09/2010
• Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation. Posted 08/09/2010
• Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient Product contains undeclared didesmethyl sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 08/09/2010
• Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient Product marketed as a dietary supplement sexual enhancer for men contains undeclared tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Posted 08/09/2010
• Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions UPDATE 08/04/2010. Dear Healthcare Professional Letter issued. New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps. Originally posted 07/08/2010
• Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays UPDATE 08/04/2010. Recall classified as Class I - balloon inflation assembly may not hold air. Originally posted 07/22/2010
• Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms IV injection can result in cardiac arrest, severe falls in blood pressure, and other heart-related complications. Posted 08/02/2010
• NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter Potential for particulate matter to result in serious adverse effects. Posted 08/02/2010
• Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure Increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age. Posted 07/30/2010
• Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach Product sold online as a dietary supplement. When consumed as instructed, produces an industrial bleach that can cause serious harm to health. Posted 07/30/2010
• Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient These products, marketed as dietary supplements, contain sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerously low levels. Posted 07/30/2010
• Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product. Posted 07/29/2010
• Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin. Posted 07/29/2010
• Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke. Posted 07/22/2010
• CONSTELLATION Vision System: Recall Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. Posted 07/20/2010
• Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil. Posted 07/20/2010
• Slim- 30 Herb Supplement: Undeclared Drug Ingredient Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Posted 07/19/2010.
• Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. Posted 07/16/2010
• June 2010 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 07/15/2010
• Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed No increase in risk of cancer with ARB blood pressure drugs. Posted 06/02/2010
• Coumadin 1 mg Tablet Blister Packs: Recall Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient. Posted 07/14/2010
• Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury Warning highlights the risk of severe liver injury in patients using this drug and how this risk may be reduced. Posted 07/13/2010
• Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products. Posted 07/09/2010
• McNeil Consumer Healthcare Over-The-Counter Products: Recall UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin. Originally posted 01/15/2010, updated 06/15/2010
• Que She Herbal Supplement: Undeclared Drug Ingredients Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions. Posted 07/08/2010
• Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection. Posted 07/02/2010
• LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure A power supply assembly failure can result in the inability to deliver defibrillation therapy. Posted 07/02/2010
• Mylotarg (gemtuzumab ozogamicin): Market Withdrawal Drug failed to demonstrate clinical benefit to patients enrolled in trials. Posted 06/21/2010
• Magic Power Coffee: Undeclared Drug Ingredient Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure. Posted 06/21/2010
• Tamiflu: Counterfeit Product Sold on Internet Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic. Posted 06/17/2010
• McNeil Consumer Healthcare Over-The-Counter Products: Recall UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin. Originally posted 01/15/2010, updated 06/15/2010
• May 2010 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 06/15/2010
• Vitamin D Supplement Products: Medication Use Error Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Posted 06/15/2010
• Benicar (olmesartan): Ongoing Safety Review UPDATED 04/14/2011. The benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Originally posted 06/11/2010
• Hospira Brand Liposyn and Propofol: Recall Injectable products may contain particulate matter. Posted 06/10/2010
• Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack. Posted 06/09/2010
• Counterfeit Polypropylene Surgical Mesh: Initial Communication [UPDATED 06/08/2010] Recall classified as Class I. Various sizes of counterfeit flat sheets of polypropylene surgical mesh marketed in the U.S. labeled with the C. R. Bard/Davol brand name. Originally posted 03/12/2010
• GammaGard Liquid, Immune Globulin Intravenous (Human) Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots. Posted 06/04/2010
• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements UPDATED 04/15/2011. FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs). Originally posted 02/18/2010
• PediaCare Children's Products [Blacksmith Brand]: Recall of four products The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices. Posted 05/29/2010
• Intravenous Medications Manufactured by Claris: Recall due to contamination of products Products sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. Reports of floating matter in intravenous bags. Foreign matter should not be present in a sterile injectable product. Posted 05/29/2010
• Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic Product contains substances which are poisonous when ingested or applied to large areas of the body. Posted 05/28/2010
• Hylenex recombinant (hyaluronidase human injection): Recall Voluntary recall of all manufactured lots has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing. Posted 5/26/2010
• Orlistat (marketed as Alli and Xenical): Labeling Change Revised labeling to include cases of severe liver injury. Posted 05/26/2010
• Proton Pump Inhibitors (PPI): Class Labeling Change UPDATED 03/23/2011 FDA determined an osteoporosis and fracture warning on the over-the-counter (OTC) proton pump inhibitor (PPI) medication “Drug Facts” label is not indicated at this time. Originally Posted 05/25/2010
• Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs. Posted 05/25/2010
• Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility Non-sterility of metronidazole injection administered via the intravenous route has the potential to result in infections, which could be fatal. Posted 05/17/2010
• Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes [UPDATED 05/17/2010] Recall has been classified as Class I. Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. Originally posted 04/24/2010
• Rotarix Vaccine: Update to Clinicians and Public Health Professionals UPDATE 05/16/2010. FDA determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Originally posted 03/22/2010
• April 2010 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.
• GE Healthcare Aisys and Avance Anesthesia Systems: Recall Defective control board wiring harnesses can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. Posted 05/12/2010
• Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease Study terminated following the identification of an imbalance of thrombosis of the portal venous system in patients treated with eltrombopag versus matching placebo. Posted 05/12/2010
• Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors Reports of consumers ingesting the gel rather than using it topically, applied to the skin. Posted 05/12/2010
• Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall Flex tube may not fit securely within the endotracheal tube (ET) connector. Posted 05/06/2010
• Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients Patients to be informed of risk of severe injection site reactions. Posted 05/04/2010
• Baxter Colleague Infusion Pumps: FDA Ordering Recall UPDATED 12/01/2010. Recall classified as Class I. Action based on failure to correct serious problems with infusion pumps. Originally posted 05/04/2010
• GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer Possible increased risk of diabetes and certain cardiovascular diseases. Posted 05/03/2010
• Vita Breath Dietary Supplement Consumers warned not to use product because it may contain hazardous levels of lead. Posted 05/03/2010
• McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall Certain over-the-counter Children’s and Infants’ liquid products may not meet required quality standards. Posted 04/30/2010
• Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010
• Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes [UPDATED 05/17/2010] Recall has been classified as Class I. Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. Originally posted 04/24/2010
• LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc. Class I Recall issued because of the potential for the device to expectedly power off and/or power on. Posted 04/22/2010
• 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.
• 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
• Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall UPDATE 04/08/2010. Recall has been classified as Class I. Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged. Originally posted 03/16/2010
• Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility Lack of sterile product has the potential to cause infections. Posted 04/07/2010
• 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.
• Stud Capsule For Men: Product contains Undeclared Drug Ingredient Product adulterated with sildenafil which may interact with nitrates to lower blood pressure to dangerous levels. Posted 04/06/2010
• Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review FDA is evaluating clinical trial data that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer. Posted 03/31/2010
• MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient UPDATED 08/25/2010. Product marketed as dietary supplement contains undeclared Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Originally posted 03/30/2010
• Rotarix Vaccine: Update to Clinicians and Public Health Professionals UPDATE 05/16/2010. FDA determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Originally posted 03/22/2010
• Boston Scientific Implantable Cardioverter Defibrillators: Recall Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer. Posted 03/19/2010
• Zocor (simvastatin): increased risk of muscle injury with high doses Ongoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs. Posted 03/19/2010
• Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream. Posted 03/18/2010
• 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]
• Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized. Posted 03/17/2010
• Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall UPDATE 04/08/2010. Recall has been classified as Class I. Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged. Originally posted 03/16/2010
• Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers. Posted 03/12/2010
• Counterfeit Polypropylene Surgical Mesh: Initial Communication [UPDATED 06/08/2010] Recall classified as Class I. Various sizes of counterfeit flat sheets of polypropylene surgical mesh marketed in the U.S. labeled with the C. R. Bard/Davol brand name. Originally posted 03/12/2010
• Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death. Posted 03/11/2010
• Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. Posted 03/11/2010
• Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell. Posted 03/11/2010
• Abiomed AB5000 Circulatory Support System: Class I Recall Device computer may shut down without an alarm, which can lead to serious injuries or death. Posted 03/10/2010
• WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho. Posted 03/10/2010
• Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010
• Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Device may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. Posted 02/09/2010
• Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death. Posted 03/05/2010
• Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. Posted 03/03/2010
• OneTouch SureStep Test Strips (LifeScan): Recall Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. Posted 02/26/2010
• StatSpin Express 4 Centrifuges Model 510: Class I Recall Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms. Posted 02/26/2010
• Invirase (saquinavir): Ongoing safety review of clinical trial data Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir). Posted 02/23/2010
• Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone. Posted 02/22/2010
• Ear Candles: Risk of Serious Injuries Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions. Posted 02/20/2010
• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements UPDATED 04/15/2011. FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs). Originally posted 02/18/2010
• Exjade (deferasirox): Boxed Warning Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage. Posted 02/18/2010
• Maalox Total Relief and Maalox Liquid Products: Medication Use Errors Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin. Posted 02/17/2010
• Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer. Posted 02/16/2010
• Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall Device may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. Posted 02/09/2010
• BD Q-Syte Luer Access Devices: Recall Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. Posted 02/09/2010
• Tysabri (natalizumab): Update of Healthcare Professional Information UPDATED 04/22/2011 Label provides new information about the size of the risk of PML, rates of PML according to number of infusions and association of risk with other drugs that suppress immune system.
• Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death. Posted 02/04/2010
• Zyprexa (olanzapine): Use in Adolescents Clinicians should consider the potential long-term risks when prescribing to adolescents. Posted 01/29/2010
• Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension Risk information added to Warnings/Precautions section and data summary provided. Posted 01/29/2010
• Edwards Lifesciences Aquarius Hemodialysis System: Recall Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm. Posted 01/28/2010
• Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall Plastic centrifuge rotor may crack, break apart and be forcefully ejected. Posted 01/28/2010
• Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted. Posted 01/26/2010
• Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored. Posted 01/26/2010
• Alli 60 mg capsules (120 count refill kit): Counterfeit Product UPDATE [01/23/2010] Previous alert updated with information on laboratory analysis of sibutramine levels in counterfeit product-Product sold over the internet contains controlled substance sibutramine. Posted 01/18/2010
• Nipro GlucoPro Insulin Syringes: Recall Needles may become detached and remain in the skin. Posted 01/22/2010
• Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review Contraindication to use in patients with history of cardiovascular disease. Posted 01/21/2010
• MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall Dietary supplements recalled due to undeclared steroids in products, posing risk of acute liver injury. Posted 01/15/2010
• McNeil Consumer Healthcare Over-The-Counter Products: Recall UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin. Originally posted 01/15/2010, updated 06/15/2010
• HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals - Recall Selected varieties recalled due to packaging defect that could cause possible bacterial contamination. Posted 01/13/2010
• Rapamune (sirolimus): Drug Monitoring Recommendations Switching between assays for the same patient can produce differing results that may be clinically significant. Posted 01/11/2010
• ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall Device may crack near the radiopaque marker band, potentially resulting in serious patient injury. Posted 01/05/2010