FDA 101: How to Use the Consumer Complaint System and MedWatch

Español If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it. FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch. 1. Consumer Complaint Reporting…

Collegeville Man Indicted for Scheme to Sell Fraudulent Canine Cancer-Curing Drugs to Pet Owners

Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASETuesday, February 4, 2020 The defendant promised to restore the health of terminally ill dogs and allegedly defrauded pet owners of hundreds of thousands of dollars PHILADELPHIA – United States Attorney William M. McSwain announced that Jonathan Nyce, 70, of Collegeville, PA, was charged by Indictment with…

New Seasons Market Recalls Grab N’ Go Vegetarian Lasagna w/Gluten Free Pasta Due to Undeclared Soy

Summary Company Announcement Date: February 06, 2020 FDA Publish Date: February 06, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy Company Name: New Seasons Market Brand Name: Brand Name(s) New Seasons Market Product Description: Product Description Grab N’ Go Vegetarian Lasagna w/Gluten Free Pasta Company Announcement New Seasons Market…

Vaccines Protect Children From Harmful Infectious Diseases

Image Español Vaccines are essential to getting children off to a healthy start in life. Because immunization programs of the 20th and 21st century have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They don’t realize that those infectious diseases could reemerge. If individuals choose not…

Allergy Alert Issued for Undeclared Milk in Bundt Cake and Chocolate Dipped Cookies Sold at 44 Whole Foods Market Stores in the Mid-Atlantic Region

Summary Company Announcement Date: February 04, 2020 FDA Publish Date: February 04, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Whole Foods Market Brand Name: Brand Name(s) Whole Foods Market Product Description: Product Description Bundt Cake and Chocolate Dipped Cookies Company Announcement Whole Foods Market is voluntarily…

Cargill Conducts Voluntary Recall of a Single Lot of Nutrebeef® Transition Pellet Due to Elevated Levels of Monesin

Summary Company Announcement Date: February 04, 2020 FDA Publish Date: February 04, 2020 Product Type: Animal & VeterinaryFood & BeveragesPet Food Reason for Announcement: Recall Reason Description May Contain Elevated levels of Monensin Company Name: Cargill Incorporated Brand Name: Brand Name(s) Product Description: Product Description NutreBeef Transition Pellet (MH) Company Announcement Cargill’s animal nutrition business…

GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values

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 Airway Gas Option N-CAiO (00840682104074) and CARESCAPE Respiratory Modules E-sCO (00840682104173), sCOVX (00840682104289, E-sCAiO (00840682104180), E-sCAiOV (00840682104142), E-sCAiOE (00840682104135), E-sCAiOVE (00840682104302) Serial numbers: Manufacturing Dates: June 7,…

Salud Natural Entrepreneur Inc. Recalls Nopalina Flax Seed Fiber Powder and Nopalina Flax Seed Fiber Capsules Because of Possible Health Risk (Updated Lot Number Information)

Summary Company Announcement Date: January 31, 2020 FDA Publish Date: February 03, 2020 Product Type: Dietary SupplementsFood & BeveragesNutritional SupplementFoodborne Illness Reason for Announcement: Recall Reason Description Potential for Salmonella Company Name: Salud Natural Entrepreneur Inc Brand Name: Brand Name(s) Product Description: Product Description Flax Seed Fiber Powder and Capsules Company Announcement This announcement provides…

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

Summary Company Announcement Date: January 31, 2020 FDA Publish Date: January 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description due to Microbial Contamination Company Name: Efficient Laboratories, Inc. Brand Name: Brand Name(s) Product Description: Product Description Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid Company Announcement Efficient Laboratories, Inc….

Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

On January 30, 2020, Medtronic released the first round of software updates to address some of the affected devices. Medtronic will issue additional rounds of software updates to address the remaining devices. These software updates will be installed on devices automatically. For more information, see Medtronic’s Security Bulletin. Date Issued March 21, 2019 Audience Patients…