Category Archives: FDA Label Change

November 2013 Safety Labeling Changes

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November 2013 Safety Labeling Changes includes 27 products with revisions to Prescribing Information The MedWatch November 2013 Safety Labeling Changes posting includes 27 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and … Continue reading

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MedWatch October 2013 Safety Labeling Changes

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The MedWatch October 2013 Safety Labeling Changes posting includes 68 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of drug names and … Continue reading

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Over the Counter Topical Antiseptic Products Drug Safety Communication

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Over-the-Counter Topical Antiseptic Products: Drug Safety Communication – FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection AUDIENCE: Healthcare Professional, Risk Manager, Pharmacy ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes … Continue reading

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MedWatch September 2013 Safety Labeling Changes

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The MedWatch September 2013 Safety Labeling Changes posting includes 49 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of product names and safety … Continue reading

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MedWatch August 2013 Safety Labeling Changes

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The MedWatch August 2013 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of product names and … Continue reading

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MedWatch July 2013 Safety Labeling Changes

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The MedWatch July 2013 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of product names and … Continue reading

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MedWatch June 2013 Safety Labeling Changes

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The MedWatch June 2013 Safety Labeling Changes posting includes over 44 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of product names … Continue reading

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MedWatch May 2013 Safety Labeling Change

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The MedWatch May 2013 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.  The “Summary Page” provides a listing of drug names and … Continue reading

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April 2013 Safety Labeling Changes

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The MedWatch April 2013 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.  The “Summary Page” provides a listing of drug names and … Continue reading

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Medical Bed Mattresses FDA Safety Communication

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Medical Bed Mattresses: FDA Safety Communication – Damaged or Worn Covers Pose Risk of Contamination and Infection AUDIENCE: Biomedical Engineering, Infectious Disease, Nursing, Risk Managers ISSUE: From January 2011 to January 2013, the FDA received 458 reports associated with medical … Continue reading

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Posted in Biomedical Engineering, FDA 2013, FDA Label Change, FDA Safety Communication, Infectious Disease, Nursing, Risk Manager | Tagged , , , , , , , , , , | Comments Off on Medical Bed Mattresses FDA Safety Communication