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…

Seafood Processor and Owner Sentenced for Selling Foreign Crab Meat Falsely Labeled as Product of USA

Department of JusticeU.S. Attorney’s OfficeEastern District of North Carolina FOR IMMEDIATE RELEASEThursday, January 9, 2020 RALEIGH – Capt. Neill’s Seafood Inc. (Capt. Neill’s) of Columbia, North Carolina, and Phillip R. Carawan, the owner, President, and Chief Executive of Capt. Neill’s, were sentenced today by U.S. District Judge Louise Flanagan, in New Bern, North Carolina. Capt….

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…

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…

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…

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…