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FDA MedWatch Safety Alerts

Last Build Date: Thu, 27 Apr 2017 13:15:00 -0400


General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children

Thu, 27 Apr 2017 13:15:00 -0400

Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.

Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

Tue, 25 Apr 2017 09:25:00 -0400

Use of unproven or unapproved products may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment.

25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter

Mon, 24 Apr 2017 10:05:00 -0400

Particulate administered to a patient could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate.

Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength

Fri, 21 Apr 2017 14:10:00 -0400

Mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.

Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women

Thu, 20 Apr 2017 11:30:00 -0400

New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.

Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients

Wed, 19 Apr 2017 08:55:00 -0400

Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.

Certain Homeopathic Teething Products: Recall - Confirmed Elevated Levels of Belladonna

Thu, 13 Apr 2017 19:00:00 -0400

Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children.

StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid

Sat, 08 Apr 2017 21:29:00 -0400

If left untreated, under-drainage can potentially lead to coma and death.

Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance

Thu, 06 Apr 2017 16:35:00 -0400

Voluntary recall of all lots of sterile products, to the hospital/user level.

Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously

Wed, 05 Apr 2017 13:40:00 -0400

Potential for ventilator reset during normal operation, without an accompanying alarm.

EpiPen and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

Fri, 31 Mar 2017 19:00:00 -0400

Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).

Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

Fri, 31 Mar 2017 13:30:00 -0400

Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.

LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

Thu, 30 Mar 2017 09:50:00 -0400

Sibutramine may 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.

HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

Fri, 24 Mar 2017 13:20:00 -0400

A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Tue, 21 Mar 2017 13:00:00 -0400

BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.

Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

Sat, 18 Mar 2017 10:00:00 -0400

Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.

Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Wed, 15 Mar 2017 12:02:00 -0400

Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.

SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

Tue, 14 Mar 2017 13:20:00 -0400

Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.

Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

Thu, 09 Mar 2017 14:23:00 -0500

Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017

Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

Thu, 09 Mar 2017 13:40:00 -0500

Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.