FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

    Summary Company Announcement Date: January 15, 2020 FDA Publish Date: January 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of Assurance of Sterility Company Name: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal Brand Name: Brand Name(s) AXIA Pharmaceutical Product Description: Product Description Sterile Drug Products Company Announcement FUSION IV Pharmaceuticals, Inc…

    Surgical Gowns and Packs by Cardinal Health: FDA Statement – Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

    [Posted 01/16/2020] AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.  FDA also understands this issue may already be impacting patient care at health care facilities, such as the cancellation of…

    Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud

    Summary Company Announcement Date: September 09, 2017 FDA Publish Date: February 06, 2018 Product Type: Food & BeveragesFood & Beverage Safety Reason for Announcement: Recall Reason Description Potential to be contaminated with salmonella Company Name: Bravo Produce Inc. Brand Name: Brand Name(s) Frutas Selectas de Tijuana, S. de R.L. of C.V. Product Description: Product Description…

    Brightfarms Announces Voluntary Regional Recall of Produce Due to Potential Presence of Metal Pieces From Construction

    Summary Company Announcement Date: May 18, 2017 FDA Publish Date: February 08, 2018 Product Type: Food & BeveragesProduceFood & Beverage Safety Reason for Announcement: Recall Reason Description Potential Prresence of Metal Pieces From Construction Company Name: BrightFarms Brand Name: Brand Name(s) BrightFarms Product Description: Product Description Salad Greens Company Announcement BrightFarms is initiating a voluntary…

    Palmer Candy Company Announces Voluntary Recall of Sea Salt Caramel Hearts

    Summary Company Announcement Date: January 17, 2018 FDA Publish Date: January 19, 2018 Product Type: Food & BeveragesAllergens Reason for Announcement: Recall Reason Description Undeclared peanut Company Name: Palmer Candy Company Brand Name: Brand Name(s) Palmer Bakery Delights Product Description: Product Description Sea Salt Caramel Hearts Company Announcement Palmer Candy Company (www.palmercandy.com), announced today a…

    Former Vice President of Insys Therapeutics Sentenced for Racketeering Conspiracy

    Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEMonday, January 13, 2020 Defendant is the first executive to be sentenced in connection with conspiracy to bribe medical practitioners to prescribe a highly-addictive opioid BOSTON – The former Vice President of Managed Markets for Insys Therapeutics was sentenced today in federal court in Boston for…

    The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

    Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result…