Issued March 10, 2011 Approval Order Summary of Safety and Probable Benefit Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated March 28, 2011
H & P Industries Povidone Iodine Prep Pads: Recall
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U-Prosta: Undeclared Drug Ingredient
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Citalopram And Finasteride by Greenstone: Recall
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FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
    Safety Announcement Additional Information for Patients and Consumers Additional Information for Healthcare Professionals Data Summary Table of epidemiological studies evaluating fracture risk with proton pump inhibitors   Safety Announcement [05-25-2010] The U.S. Food and Drug Administration (FDA) is revising the prescription and over-the-counter (OTC) labels for a class of drugs called proton pump…
Warning Letters 2011
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Clinical Investigator Inspection List (CLIIL)
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Class I Medical Device Recall: Roche Insulin Delivery Systems, ACCU-CHEK FlexLink Plus Infusion Sets
Recall Class: Class I Date Recall Initiated: February 24, 2011 Product: ACCU-CHEK FlexLink Plus Infusion Set This recall ONLY applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are NOT affected by this recall and can be continued as directed by…
Class I Medical Device Recall: Millar Instruments Inc., Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F
Recall Class: Class I Date Recall Initiated: March 8, 2011 Product: Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F This recall includes all catheters of these models that did not expire prior to March 2011. See Firm Press Release under Additional Links below. This product was manufactured and distributed from March 1, 2009 through February, 28,…
CDRH Plan of Action for 510(k) and Science (Added CDRH Center Science Council Draft Charter and FAQs)
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