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FDA MedWatch Safety Alerts

Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall-Weak or Open Seals

11/23/2010 12:15 PM

These medical products could become or have been contaminated due to compromise in sterility and can cause serious adverse health consequences and/or death.

Propoxyphene: Withdrawal - Risk of Cardiac Toxicity

11/19/2010 12:35 PM

New data shows that Propoxyphene and Propoxyphene-containing products can cause serious toxicity to the heart, even when used at therapeutic doses.

Vigor-25: Undeclared Drug Ingredient-Sold as natural dietary supplement

11/19/2010 12:00 AM

Marketed as a natural dietary supplement to enhance male sexual performance and contains undeclared drug that can dangerously lower blood pressure

Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems

11/18/2010 11:50 AM

Syringes may malfunction, break, or become clogged during the process of attempting to connect to some needleless IV access systems.

Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

11/14/2010 08:00 AM

Unit may fail suddenly, causing inaccurate flow,back flow,over-infusion, and free flow. Pump does not issue an alarm when this occurs and could result in serious injury or death.

VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed

11/10/2010 10:55 AM

Incorrect results could potentially lead to patients being inappropriately treated with Piperacillin/Tazobactam, which could cause serious injury or death.

Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

11/08/2010 09:40 AM

The recalled pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.

Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient

11/05/2010 11:20 AM

Product marketed as dietary supplement contains undeclared Sulfoaidenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified

11/05/2010 09:30 AM

UPDATED 11/05/2010. Consumers encouraged to return any product in their possession from the October 2010 recall. Originally posted 10/22/2010

Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures

11/04/2010 01:15 PM

Infusers may cease operation and exhibit an audible and visual alarm. Delay or interruption of infusion therapy may result in serious injury or death.

Octopus Nuvo Tissue Stabilizer: Class I Recall - Potential for Device Fracture

11/01/2010 05:45 PM

Fragments of the device could fall into the patient’s chest cavity and damage the heart tissue.

Heparin Sodium (B. Braun): Recall - Trace Contaminant

10/29/2010 03:55 PM

Oversulfated chondroitin sulfate (OSCS) contaminant found during sample testing.

Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates

10/29/2010 12:18 PM

Potential to develop adverse reactions in areas where the particles lodge, which could result in serious adverse events, disability, or death.

Hyland’s Teething Tablets: Recall - Risk of Harm to Children

10/24/2010 12:12 AM

FDA laboratory analysis found product to contain inconsistent amounts of belladonna, which can cause harm at larger doses.

Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm

10/21/2010 01:55 PM

Prolonged QT or PR intervals reported when Invirase is used with the antiviral medication, Norvir (ritonavir).

GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)

10/20/2010 03:30 PM

New information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

Tylenol 8 Hour Caplets 50 Count: Recall

10/19/2010 03:20 PM

Uncharacteristic musty or moldy odor.

Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility

10/15/2010 03:30 PM

Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy

10/15/2010 02:50 PM

Hardware communication error may lead to serious injury or death.

Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning

10/14/2010 01:50 PM

Consumers advised to avoid OTC chelation products because of the potential for serious harm associated with their use, including dehydration, kidney failure, and death.



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