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FDA Safety Alerts
  • Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance

    Thursday, September 22, 2016 1:50:00 PM CST
    Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening. [...] Read More..
  • Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

    Thursday, September 15, 2016 10:20:00 AM CST
    Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. [...] Read More..
  • GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe

    Friday, September 09, 2016 1:07:00 PM CST
    Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. [...] Read More..
  • Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

    Thursday, September 08, 2016 7:20:00 AM CST
    Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection. [...] Read More..
  • Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

    Wednesday, September 07, 2016 4:17:00 PM CST
    Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection. [...] Read More..
  • Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use

    Wednesday, September 07, 2016 1:40:00 PM CST
    Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer. [...] Read More..
  • Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall - Raw Materials Issue

    Tuesday, September 06, 2016 3:40:00 PM CST
    UPDATED 09/06/2016 Recall classified as Class I. Recalled Device and Discontinuation of the Product line [...] Read More..
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  • Mass Spectrometers by Sciex: Safety Communication - Incorrect Assignment of Test Results

    Thursday, September 01, 2016 11:40:00 AM CST
    Health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices, which may lead to serious adverse health consequences. [...] Read More..
  • Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

    Thursday, September 01, 2016 8:00:00 AM CST
    Reports of intraoperative or postoperative bleeding and hematomas, some of which required additional intervention, and three patient deaths potentially related to this issue that occurred shortly after carotid endarterectomy surgery. [...] Read More..
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  • Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death

    Wednesday, August 31, 2016 11:01:00 AM CST
    Combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths. [...] Read More..
  • Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

    Tuesday, August 30, 2016 3:30:00 PM CST
    UPDATED 08/30/2016. Company press release with additional information added. Recall expanded to include all lots of DHZC-2 tablets. [...] Read More..
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  • Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

    Monday, August 29, 2016 2:17:00 PM CST
    Patients could take less than their intended lamotrigine dose, which may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms. [...] Read More..
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Avoiding Drug Interactions

Avoiding Drug Interactions
People often combine foods. For example, chocolate and peanut butter might be considered a tasty combination. But eating chocolate and taking certain drugs might carry risks. In fact, eating chocolate and taking monoamine oxidase...
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