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Alerts and Recalls

  • Oral Liquid Docusate Sodium by PharmaTech: Recall – Contaminated with B. Cepacia

    Saturday, July 16, 2016

    The FDA is alerting healthcare professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.

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  • INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results

    Thursday, July 14, 2016

    Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System.

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  • Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication – Serious Bleeding Risk

    Thursday, July 14, 2016

    The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.

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  • UNOS/OPTN Zika Bulletin

    Tuesday, July 12, 2016

    UNOS/OPTN has issued a bulletin covering Guidance for Organ Donation and Transplantation Professionals Regarding the Zika Virus including notation about transfusion. Much information remains unknown, and the Guidance revolves around recent donor travel history and risk considerations, with the warning that vulnerability to Zika may also mean vulnerability to Dengue and Chikungunya.

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  • Zika Updates

    Monday, June 20, 2016

    The following information has been added to or recently updated on the CDC Zika and CDC Travelers’ Health sites.

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  • Alert to U.S. Healthcare Facilities: First mcr-1 Gene in E. coli Bacteria found in a Human in the United States

    Tuesday, June 14, 2016

    The Centers for Disease Control and Prevention (CDC) is collaborating in a coordinated public health response to the Department of Defense (DoD) announcement on May 26 of the first mcr-1 gene found in bacteria from a human in the United States. Escherichia coli (E. coli) bacteria carrying the mcr-1 gene were found in a urine sample from a person in Pennsylvania with no recent travel outside of the United States who presented to a clinic with a urinary tract infection. 

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  • Zecuity (sumatriptan) Migraine Patch: UPDATED Drug Safety Communication – FDA Evaluating Risk of Burns and Scars

    Monday, June 13, 2016

    FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.

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