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Alerts and Recalls

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  • CDC Guidance for Travel and Testing of Pregnant Women for Zika

    Tuesday, August 2, 2016

    The Florida Department of Health (FL DOH) has identified an area with local mosquito-borne Zika virus transmission (active Zika virus transmission) in Miami. Based on the earliest time of symptom onset and a maximal two-week incubation period for Zika virus, this guidance applies to women of reproductive age and their partners who live in or traveled to this area after June 15, 2016.

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  • 2016 DOHMH Advisory #26: Tick-borne Disease Advisory

    Monday, August 1, 2016

    New York City (NYC) clinicians should be on the alert for patients with tick-borne diseases. This advisory presents key epidemiologic findings regarding reportable tick-borne diseases (TBD) in NYC and reminds clinicians of reporting requirements.

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  • FDA: Saety Alert - Comfort Shield Barrier Cream Cloths by Sage Products -Recall

    Monday, August 1, 2016

    Sage Products is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening.

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  • Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication – Warnings Updated Due to Disabling Side Effects

    Wednesday, July 27, 2016

    FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

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  • Zika Update: New FDA Recommendations

    Wednesday, July 27, 2016

    In consideration of the possibility of local Zika virus transmission, FDA has issued new donor screening recommendations for blood collection centers in Broward County, Florida and Miami-Dade County, Florida.

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  • 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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