Last Build Date: Thu, 01 Dec 2016 08:40:00 -0500
Thu, 01 Dec 2016 08:40:00 -0500Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Thu, 01 Dec 2016 08:15:00 -0500Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Sat, 26 Nov 2016 10:00:00 -0500DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Fri, 25 Nov 2016 00:00:00 -0500The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Tue, 22 Nov 2016 14:50:00 -0500Can lead to serious adverse health consequences including embolism, stroke, or death.
Mon, 21 Nov 2016 15:00:00 -0500Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.
Mon, 21 Nov 2016 12:30:00 -0500Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Fri, 18 Nov 2016 14:00:00 -0500People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Tue, 15 Nov 2016 12:10:00 -0500Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
Tue, 08 Nov 2016 15:50:00 -0500Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Tue, 08 Nov 2016 09:15:00 -0500Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
Fri, 28 Oct 2016 14:45:00 -0400Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.
Wed, 26 Oct 2016 11:00:00 -0400The most recent post-approval study results assessing post-market performance is available.
Tue, 25 Oct 2016 12:29:00 -0400New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
Mon, 24 Oct 2016 00:00:00 -0400Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Thu, 20 Oct 2016 14:00:00 -0400Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
Thu, 20 Oct 2016 09:30:00 -0400The FDA is concerned that health care providers may be unaware of the risks associated with these devices.
Tue, 18 Oct 2016 12:01:00 -0400PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Fri, 14 Oct 2016 14:30:00 -0400User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy.
Thu, 13 Oct 2016 15:00:00 -0400New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.