Wallace & Graham

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Dangerous Drugs & Medical Devices

CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR) — FDA issues a safety warning related to diabetes medicine and amputations

Updated June 19, 2017 In the News: Drug Safety                                                         FDA issues a safety warning related to diabetes medicine CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR)  On March 16, 2017, the Food and Drug Administration…

INACCURATE LEAD TESTING KITS

In the News: INACCURATE LEAD TESTING KITS May 18, 2017 The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are warning Americans that some Lead testing systems may provide inaccurate results. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) warning that all four of Magellan Diagnostics’ lead…

FDA Warning of Power Morcellator

Cancer can be Cause by Laparoscopic Hysterectomies The Food and Drug Administration has recently warned of the possibility of cancer being spread in a woman’s bottom during a laparoscopic hysterectomy. Each year, a half a million women in the United States undergo hysterectomies.  These are normally done due to “fibroids” which are benign growths in the uterus that can cause pain, bleeding and other symptoms.  These…

Potentially Dangerous Food and Drug Products

The following recalls of potentially dangerous food and drug products were announced by FDA: Alexion Pharmaceuticals, Inc. initiated a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion.  These lots were manufactured in such a way as to create a particulate in the solution which, if administered, could cause immune reactions and blood…

Health Risks Associated with Medical Products

The FDA has recently announced the following health risks associated with medical products: Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall – May Not Properly Delay an Infusion.  Infusion start times earlier or later than intended could result in serious injury or death. Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall – Failure…