| Tygacil (tigecycline): Label Change - Increased Mortality Risk |
| 09/01/2010 10:00 AM |
| Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.Read more... |
| Huber Needles: Recall - Risk of Coring |
| 08/26/2010 03:40 PM |
| Risk of infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs.Read more... |
| Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens |
| 08/26/2010 02:30 PM |
| Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.Read more... |
| TimeOut Capsules: Undeclared Drug Ingredient |
| 08/25/2010 03:25 PM |
| 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.Read more... |
| MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient |
| 08/25/2010 12:38 PM |
| 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.Read more... |
| Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events |
| 08/25/2010 11:00 AM |
| Customers asked to immediately quarantine the use of affected lots due to the potential for serious thromboembolic events.Read more... |
| Mr. Magic Male Enhancer: Undeclared Drug Ingredient |
| 08/24/2010 11:15 AM |
| Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil and sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.Read more... |
| INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow |
| 08/23/2010 08:50 PM |
| Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.Read more... |
| Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk |
| 08/20/2010 12:00 AM |
| FDA evaluating clinical trial data that suggest patients taking drug may be at an increased risk for cardiovascular events compared to those taking carbidopa/levodopaRead more... |
| Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug |
| 08/16/2010 03:45 PM |
| 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.Read more... |
| 6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub |
| 08/13/2010 02:35 PM |
| Potentially life threatening episode of bleeding could occur during surgical procedures.Read more... |
| Prolatis’: Undeclared Drug Ingredient |
| 08/13/2010 09:55 AM |
| 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.Read more... |
| Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis |
| 08/12/2010 03:14 PM |
| Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis.Read more... |
| Novacare LLC Products: Recall - Undeclared Drug Ingredient |
| 08/11/2010 02:00 PM |
| 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.Read more... |
| Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product |
| 08/09/2010 01:30 PM |
| 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.Read more... |
| Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use |
| 08/09/2010 11:20 AM |
| Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.Read more... |
| Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient |
| 08/09/2010 09:25 AM |
| 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.Read more... |
| Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient |
| 08/09/2010 09:05 AM |
| 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.Read more... |
| Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions |
| 08/04/2010 12:38 PM |
| 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 07/08/2010Read more... |
| Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays |
| 08/04/2010 10:35 AM |
| UPDATE 08/04/2010. Recall classified as Class I - balloon inflation assembly may not hold air. Originally posted 07/22/2010Read more... |