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FDA MedWatch Safety Alerts

Last Build Date: Thu, 01 Dec 2016 08:40:00 -0500


Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients

Thu, 01 Dec 2016 08:40:00 -0500

Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient

Thu, 01 Dec 2016 08:15:00 -0500

Sibutramine 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.

DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk

Sat, 26 Nov 2016 10:00:00 -0500

DMAA 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.

Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids

Fri, 25 Nov 2016 00:00:00 -0500

The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.

FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation

Tue, 22 Nov 2016 14:50:00 -0500

Can lead to serious adverse health consequences including embolism, stroke, or death.

Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance

Mon, 21 Nov 2016 15:00:00 -0500

Administration 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.

Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

Mon, 21 Nov 2016 12:30:00 -0500

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk

Fri, 18 Nov 2016 14:00:00 -0500

People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.

Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes

Tue, 15 Nov 2016 12:10:00 -0500

Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.

Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients

Tue, 08 Nov 2016 15:50:00 -0500

Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Side Head Regulator TT Tablet by Life Rising/Ton Shen Health: Recall - Elevated Levels of Lead

Tue, 08 Nov 2016 09:15:00 -0500

Acute 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

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding

Fri, 28 Oct 2016 14:45:00 -0400

Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.

TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results

Wed, 26 Oct 2016 11:00:00 -0400

The most recent post-approval study results assessing post-market performance is available.

Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

Tue, 25 Oct 2016 12:29:00 -0400

New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues

Mon, 24 Oct 2016 00:00:00 -0400

Contamination 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.

Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use

Thu, 20 Oct 2016 14:00:00 -0400

Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.

Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients

Thu, 20 Oct 2016 09:30:00 -0400

The FDA is concerned that health care providers may be unaware of the risks associated with these devices.

Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Tue, 18 Oct 2016 12:01:00 -0400

PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.

Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue

Fri, 14 Oct 2016 14:30:00 -0400

User 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.

Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections

Thu, 13 Oct 2016 15:00:00 -0400

New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.