The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product LeMaitre Over the Wire Embolectomy Catheter Catalog Numbers and Lot Numbers: See full list Manufacturing Dates : May 5, 2014 to July 17, 2019 Distribution Dates: November…
U.K. National Charged with Shipping Mislabeled and Unapproved ‘Treatments’ for Patients Suffering from COVID-19
Department of JusticeU.S. Attorney’s OfficeCentral District of California FOR IMMEDIATE RELEASEWednesday, April1, 2020 LOS ANGELES – A British man was named today in a federal criminal complaint that charges him with smuggling into the United States mislabeled drugs purported to be a treatment for those suffering from COVID-19, the disease caused by the novel coronavirus. Frank…
All Ranitidine Products (Zantac): Press Release – FDA Requests Removal
[Posted 04/01/2020] ISSUE: The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen…
Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Pipeline Flex Embolization Device (Available in the US) and Pipeline Flex Embolization Device with Shield Technology (Not Available in the US) Product Codes: Pipeline Flex Embolization Device:…
CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product BodyGuard Infusion Pump Systems All Serial Numbers of Affected Model Numbers Model Numbers: BG 323 Pump* BodyGuard 121 Twins Pump* BodyGuard 545 ColorVision Pump * BodyGuard 575…
Allergy Alert Issued By Winter Gardens Quality Foods, Inc. for Undeclared Milk in Vodka Sauce
Summary Company Announcement Date: March 26, 2020 FDA Publish Date: March 26, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Winter Gardens Quality Foods, Inc. Brand Name: Brand Name(s) Whole Foods Market Product Description: Product Description Vodka Sauce Company Announcement Winter Gardens Quality Foods, Inc., is voluntary…
Safely Using Hand Sanitizer
Image Each of us can help stop the spread of COVID-19 disease by washing our hands regularly with soap and water for 20 seconds – especially after going to the bathroom, before eating, and after coughing, sneezing, or blowing your nose. If soap and water are not available, the Centers for Disease Control and Prevention recommend that…
Dr. Reddy’s Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening
Summary Company Announcement Date: March 26, 2020 FDA Publish Date: March 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Ampules breaking & shattering Company Name: Dr. Reddy’s Laboratories Ltd. Brand Name: Brand Name(s) Dr. Reddy’s Laboratories Ltd. Product Description: Product Description Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules Company Announcement Dr….
Food Safety and Availability During the Coronavirus Pandemic
Image The U.S. Food and Drug Administration is working in many ways to help keep people safe while the nation is coping with the coronavirus pandemic (COVID-19). Food availability and food safety are vitally important to our well-being, and the FDA is working hard to help ensure the foods you, your family, and your pets eat…
Tiffany Food Corp. Issues Alert on Undeclared Sulfites in Huangfushanzen Dried Mushrooms
Summary Company Announcement Date: March 24, 2020 FDA Publish Date: March 24, 2020 Product Type: Food & BeveragesAllergens Reason for Announcement: Recall Reason Description Undeclared Sulfites Company Name: Tiffany Food Corporation Brand Name: Brand Name(s) Huangfushanzen Huang Mountain Tea Mushroom Product Description: Product Description Dried Mushrooms Company Announcement Tiffany Food Corp. of Brooklyn, NY is…