FDA MedWatch Safety Alerts
Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients
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
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
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
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
Can lead to serious adverse health consequences including embolism, stroke, or death.
Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance
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
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
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
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
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
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
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
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
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
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
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
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
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
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
New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.
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