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Presentations posted for June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Nature Made (Various Products) by Pharmavite LLC: Recall
[Posted 06/08/2016] AUDIENCE: Consumer ISSUE: Pharmavite LLC is recalling specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever,…
24 Hour Summary posted for June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Step 2 60 Gold by The Body Shot Bar: Recall
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Loperamide (Imodium): Drug Safety Communication
[Posted 06/07/2016] AUDIENCE: Pharmacy, Cardiology, Internal Medicine, Pain Management, Consumer ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart…
Webinar: Announcing Final Guidance on Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act and FDA Webinar on the Final Guidance on June 28, 2016
On June 28, 2016, the FDA will hold a webinar for industry to review the Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act guidance document. Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance…
Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication
[Posted 06/06/2016] AUDIENCE: Consumer ISSUE: 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. These widely used products…
Summary Information for: Bard® LifeStent Vascular Stent System
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May 2016 PMA Approvals
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