MedWatch Safety Alerts, Jan 01 - Dec 31 2013

• Bullet Proof: Public Notification - Undeclared Drug Ingredient Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Posted 05/07/2013
• Lightning Rod Capsules: Recall - Undeclared Drug Ingredient Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels. Posted 05/07/2013
• Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. Posted 05/07/2013
• Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided. Posted 05/07/2013
• Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized Use of these non-sterile products could increase the risk of infection in surgical patients. Posted 05/07/2013
• Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death. Posted 05/07/2013
• Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. Posted 05/06/2013
• Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion Use of the incorrect nonproprietary name for Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab). Posted 05/06/2013
• American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient Laboratory analysis has found tadalafil and sildenafil. Posted 05/02/2013
• Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage UPDATED 05/01/2013. Damage from battery leakage may cause the device to shut off without warning. Originally posted 04/29/2013
• Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I Recall - Unit Goes Into Internal Backup Battery Sooner Than Expected The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power. Posted 05/01/2013
• Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified The platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added”. Posted 04/30/2013
• Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca. Posted 04/30/2013
• Piperacillin and Tazobactam for Injection, USP 40.5 grams: Recall - Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution Administration of precipitated Piperacillin/Tazobactam can lead to serious adverse events. Posted 04/30/2013
• Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration Pigment changes in the retina have the potential to cause serious eye disease with loss of vision. Posted 04/26/2013
• Eba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall - Allergy Alert On Undeclared Milk Components Incidents of being sick and experiencing anaphylactic reactions have been reported by customers taking Eba Multivitamins. Posted 04/26/2013
• Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter Use may result in local inflammation, phlebitis, and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the body. Posted 04/26/2013
• GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I Recall - Device May Randomly Delete Stored Information When Powered On Inaccurate temperature can result in hypothermia or hyperthermia, and inaccurate oxygen regulation can result in hypoxia or hyperoxia. Posted 04/24/2013
• LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I Recall: Failure to Provide a Warning at Extremely High Blood Glucose Levels At extremely high blood glucose levels of 1024 mg/dL and above, the meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 600 mg/dL” Posted 04/23/2013
• All Sterile Compounded Products by Nora Apothecary And Alternative Therapies: Recall - Lack of Sterility Assurance Patients are at increased risk for serious infections in the event a sterile product is compromised. Posted 04/23/2013
• CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall - Communication Error When Attached to EtCO2 or SpO2 Modules May lead to termination of an infusion, which could result in serious injury or death. 04/22/2013
• Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance Patients are at increased risk for infections in the event a sterile product is compromised. Posted 04/22/2013
• Medical Bed Mattresses: FDA Safety Communication - Damaged or Worn Covers Pose Risk of Contamination and Infection Damaged or worn covers can allow blood and body fluids to penetrate medical bed mattresses, posing a risk of infection to patients. Posted 04/19/2013
• Stryker Orthopaedics – ShapeMatch Cutting Guide: Class 1 Recall Defect in software has caused wider cutting ranges. Posted 04/18/2013
• Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns In the event a sterile product is compromised, patients are at risk for serious and possible life threatening infections. Posted 04/16/2013
• Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns In the event a sterile product is compromised, patients are at risk for serious and possible life threatening infections. Posted 04/16/2013
• March 2013 Safety Labeling Changes includes 53 products with revisions to Prescribing Information. Posted 04/15/2013
• Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns Lack of sterility assurance and concerns associated with quality control processes. Posted 04/11/2013
• Affirm XL: Recall - Undeclared Drug Ingredient Dietary supplement - potential health risk - contains sildenafil. Posted 04/10/2013
• BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms When used with some remote nurse alarm systems and may cause serious adverse health consequences, including death. Posted 04/09/2013
• ROCK-It MAN Male Enhancement Capsules: Recall - Undeclared Drug Ingredient Lab tests revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels. Posted 04/09/2013
• Animas Corporation 2020 Insulin Infusion Pump: Class I Recall - False Alarm or Warning Sound Use of recalled device may lead to unintended delivery of insulin, placing patients in danger of potential serious health risks, such as hypoglycemia. Posted 04/05/2013
• BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Recall - Visible Particles Observed During routine inspection, one lot showed presence of visible particles. Posted 04/05/2013
• Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates Administration of solution containing brass particulate may result in occlusion of small blood vessels, copper toxicity, hemolysis and liver toxicity, or hepatic necrosis which may be fatal. Posted 04/01/2013
• Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall - Risk of Air Being Introduced Into Device Use of the affected devices may lead to an air embolism, which could cause death. Posted 03/27/2013
• Pallimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed Use of recalled products may result in damage or obstruction of blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material. Posted 03/27/2013
• Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall - Defect in CAS I/II Absorbers May cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. Posted 03/26/13
• Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance Expanded recall follows the firm’s initial recall of Avastin. Posted 03/21/2013
• Med Prep Consulting Inc. Compounded Products: Recall - Potential Mold Contamination UPDATED 03/21/2013. Recalled products distributed through 03/17/2013. Administration of an intravenous product contaminated with mold could result in a fatal infection in a broad array of patients. Originally posted 03/18/2013
• Avastin Unit Dose Syringes by Clinical Specialties: Recall - Potential For Serious Eye Infection Clinical Specialties received reports of five intra-ocular infections from physician’s office. Posted 03/20/2013
• Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting May permit solutions to flow at a higher rate than intended, and may cause serious adverse health consequences, including death. Posted 03/18/2013
• Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious Tissue Damage and Patient Death UPDATE 03/15/2013. Continued reports of serious tissue damage and patient death. Originally posted 10/05/2012
• Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas Unpublished new findings by a group of academic researchers suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia. Posted 03/14/2013
• February Safety Labeling Changes Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 03/12/2013
• Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms FDA is warning the public that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Posted 03/12/2013
• Night Bullet: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains drug ingredients Sulfohydroxyhomosildenafil and Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels. Posted 03/12/2013
• Ad-Tech Macro Micro Subdural Electrodes: Class 1 Recall-Potential for Abrasion of Brain Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. Posted 03/07/2013
• Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death FDA continues to gather information on the circumstances surrounding the patient’s death. Posted 02/26/2013
• Lumenis VersaCut Tissue Morcellator: Class 1 Recall - Labeling Correction - Potential For Air Embolisms To Occur If Tubing Is Hooked Up Backwards This product may cause serious adverse health consequences, including death. Posted 02/25/2013
• Maxiloss Weight Advanced Softgels: Recall - Undeclared Drug Ingredient Product marketed as dietary supplement contains drug ingredient Sibutramine, and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 02/25/2013
• Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions Use of Omontys may result in serious hypersensitivity reactions including anaphylaxis, which may be life-threatening or fatal. Posted 02/23/2013
• DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall - Taper Connection May Not Accommodate Physiologic Loads Fracture of the sleeve at the taper joint may lead to loss of function or loss of limb, infection, compromised soft tissue or death. Posted 02/22/2013
• Codeine Use in Certain Children After Tonsillectomy and/or Adenoidectomy: Drug Safety Communication - Risk of Rare, But Life-Threatening Adverse Events or Death UPDATED 02/20/2013. New BOXED WARNING added to the drug labels of codeine-containing products. Originally posted 08/15/2012
• Reumofan Plus: Recall - Undeclared Drug Ingredient UPDATED 02/19/2013. Reumofan Plus USA, LLC & Reumofan USA, LLC is Voluntarily Recalling all lots of Reumofan Plus Tablets Due to Undeclared Drug Ingredients. Originally posted 06/01/2012.
• Vistide (Cidofovir Injection) by Gilead: Recall - Presence Of Particulate Matter The effects from intravenous injection of products with particulate matter can vary depending on the amount of particulate matter injected into the patient. Posted 02/16/2013
• GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall - Potential reversal of oxygen/air Potential reversal of oxygen/air concentrations may cause serious adverse health consequences, including death. Posted 02/14/2013
• St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall - Core Wire May Fracture Core wire fracture may lead to serious adverse health consequences, including death. Posted 02/13/2013
• January 2013 Safety Labeling Changes includes 27 products with revisions to Prescribing Information. Posted 02/08/2013
• Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower Possible miscalculation of oxygen supply Posted 02/07/2013
• Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume these products. Posted 02/04/2012
• Vycor Viewsite Brain Access System (VBAS): Class 1 Recall - Unidentified Fiber Found on Device This product may cause serious adverse health consequences, including death. Posted 01/30/2013
• Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility One confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. Posted 01/28/2013
• Super Power: Recall - Undeclared Ingredient Finished product of Super Power was tested and found to contain trace amounts of sildenafil. Posted 01/28/2013
• Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury Large clinical trial findings of significant elevations of both ALT and bilirubin. Posted 01/25/2013
• Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD): Class I Recall - Cannulas May Leak or Detach From the Syringe Some disposable cannulas provided may leak viscoelastic material or detach from the syringe during injection. In rare incidences, detachment has resulted in serious patient injury. Posted 01/23/2013
• Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets Serious adverse events may include impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Posted 01/18/2013
• Metal-on-Metal Hip Implants: Safety Communication - Updated Safety Recommendations Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. Posted 01/17/13
• December 2012 Safety Labeling Changes includes 42 products with revisions to Prescribing Information. Posted 1/15/2013
• Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products. Originally posted 01/10/2013
• Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes Pinholes could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Posted 01/07/2013
• Mobius brand Mitosol (mitomycin for solution) Kit for Ophthalmic Use: Recall-May Not be Sterile May contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. Posted 1/10/13
• Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units: Class I Recall - Risk of Fire Inside Cylinder Unit Physical impact such as dropping or knocking over the cylinder unit may lead to fires, and users may experience burns or a lack of oxygen (hypoxia). Posted 01/03/2013