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FDA MedWatch – CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action – Loss of Anesthetic Gases, Ventilation and Oxygenation

CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action¬†– Loss of Anesthetic Gases, Ventilation and Oxygenation AUDIENCE: Anesthesiology, Risk Manager ISSUE: Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated…

Posted on January 2, 2014 in FDA MedWatch, , , , ,


FDA MedWatch – Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning – Undeclared Ingredients

Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning – Undeclared Ingredients AUDIENCE: Consumer, Health Professional ISSUE: The FDA is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been…

Posted on December 26, 2013 in FDA MedWatch, , , , , ,


FDA MedWatch – Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall – Presence of Particulate Matter

Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall – Presence of Particulate Matter AUDIENCE: Risk Manager, Pharmacy, Anesthesiology ISSUE: Hospira initiated a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due…

Posted on December 26, 2013 in FDA MedWatch, , , , , , ,


FDA MedWatch – Methylphenidate ADHD Medications: Drug Safety Communication – Risk of Long-lasting Erections

Methylphenidate ADHD Medications: Drug Safety Communication – Risk of Long-lasting Erections Including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR AUDIENCE: Psychiatry, Family Medicine, Consumer ISSUE: FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances…

Posted on December 19, 2013 in FDA MedWatch, , , , , , , , , , , , , , , , ,


FDA MedWatch – Abrams Royal Pharmacy Sterile Products – Recall – Lack of Sterility Assurance

Abrams Royal Pharmacy Sterile Products – Recall – Lack of Sterility Assurance AUDIENCE: Pharmacy, Consumer ISSUE:¬† Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall. Sterile products are injectable medications,…

Posted on December 19, 2013 in FDA MedWatch, , , , , ,


FDA MedWatch – Nipple Aspirate Test: Safety Communication – Breast Cancer Screening Test Is Not An Alternative To Mammography

Nipple Aspirate Test: Safety Communication – Breast Cancer Screening Test Is Not An Alternative To Mammography AUDIENCE: Radiology, Pathology, Internal Medicine, Obstetrics/Gynecology, Oncology ISSUE: The FDA is alerting the public, including women and health care providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and…

Posted on December 12, 2013 in FDA MedWatch, , , , ,


FDA MedWatch – November 2013 Drug Safety Labeling Changes includes 27 products with revisions to Prescribing Information

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 PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of product names and safety labeling…

Posted on December 6, 2013 in FDA MedWatch, , , , , , , , , , ,


FDA MedWatch – HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock

HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication – Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock AUDIENCE: Risk Manager, Emergency Medicine, Health Professional ISSUE: FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare. Certain HeartStart automated external defibrillator¬†(AED) devices made by Philips…

Posted on December 4, 2013 in FDA MedWatch, , , , , ,


FDA MedWatch – Onfi (clobazam): Drug Safety Communication – Risk of Serious Skin Reactions

Onfi (clobazam): Drug Safety Communication – Risk of Serious Skin Reactions AUDIENCE: Neurology, Pharmacy, Dermatology ISSUE: FDA is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. FDA approved changes to the Onfi drug label and the patient Medication Guide…

Posted on December 4, 2013 in FDA MedWatch, , , , , ,


FDA MedWatch – FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall – Erroneously Low Blood Glucose Results

FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall – Erroneously Low Blood Glucose Results AUDIENCE: Consumer, Family Physician, Pharmacy ISSUE: Abbott is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood…

Posted on December 2, 2013 in FDA MedWatch, , , , , , ,