Medical Device and Pharmaceutical News
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FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after reviewing the company’s website and determining that its “Edral-17t” product was marketed as an unapproved new drug. FDA cited claims that the...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after purchasing and reviewing products sold through Amazon’s website and fulfilled through Amazon’s logistics network. The products identified were...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs. The...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued a coordinated series of warning letters targeting companies marketing unapproved drug products online, signaling an intensified enforcement...
FDA Approves First Treatment to Reduce Risk of Acute Pancreatitis
FDA Approves First Treatment Proven to Reduce Acute Pancreatitis Risk in Severe HypertriglyceridemiaAn important example of the distinction between surrogate endpoints and clinical outcomes in drug development The U.S. Food and Drug Administration (FDA) has approved...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep Pads appears straightforward. A commonly used healthcare product was found to be contaminated with Paenibacillus phoenicis, creating a potential...
Early Alert: Windstone Medical Recall for Convenience Kits
FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal...
Webcol Alcohol Prep Pads Recall Due to Microbial Contamination
Cardinal Health Recalls Alcohol Prep Pads Over Infection Risk Concerns Cardinal Health has issued a voluntary nationwide recall of select lots of its Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) after testing identified microbial contamination with...
FDA Issues Warning Letter for Modifications to Infant Products
FDA Issues Warning Letter to Happiest Baby Over SNOO Smart Sleeper Modifications and Quality System Deficiencies The U.S. Food and Drug Administration has issued a Warning Letter to Happiest Baby, Inc., manufacturer of the SNOO Smart Sleeper, citing unapproved device...
FDA Expands Draeger Atlan Anesthesia Workstation Correction
More anesthesia machines added to correction for potential ventilation failure The U.S. Food and Drug Administration (FDA) has designated a recent expansion of Draeger, Inc.'s Atlan anesthesia workstation correction as a Class I recall, the agency's most serious...