Archive | August, 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.
Continue reading...Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product
9. August 2010
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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.
Continue reading...Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
9. August 2010
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Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.
Continue reading...Solo Slim, Solo Slim Extra Strength: Recall – Undeclared Drug Ingredient
9. August 2010
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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.
Continue reading...Revivexxx Extra Strength: Recall – Undeclared Drug Ingredient
9. August 2010
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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.
Continue reading...Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy – Risk of serious hematological reactions
4. August 2010
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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
Continue reading...Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
4. August 2010
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UPDATE 08/04/2010. Recall classified as Class I - balloon inflation assembly may not hold air. Originally posted 07/22/2010
Continue reading...Nimodipine Oral Capsules: Medication Errors – IV Administration May Result in Death, Serious Harms
2. August 2010
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IV injection can result in cardiac arrest, severe falls in blood pressure, and other heart-related complications.
Continue reading...NeoProfen (ibuprofen lysine) Injection: Recall and Shortage – Risk of Particulate Matter
2. August 2010
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Potential for particulate matter to result in serious adverse effects.
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11. August 2010
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