Summary Company Announcement Date: May 12, 2020 FDA Publish Date: May 15, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains lead Company Name: Summitt Labs Brand Name: Brand Name(s) KORE ORGANIC Product Description: Product Description Watermelon CBD oil tincture Company Announcement Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon…
Coronavirus Testing Basics
You’ve probably heard a lot about coronavirus testing recently. If you think you have coronavirus disease 2019 (COVID-19) and need a test, contact your health care provider immediately. The FDA has been working around the clock to increase the availability of critical medical products, including tests for the coronavirus, to fight the COVID-19 pandemic. Learn…
Ramar Foods Recalls Mint Chocolate Chip With Hidden Spinach Ice Cream Because of Possible Health Risk
Summary Company Announcement Date: May 14, 2020 FDA Publish Date: May 14, 2020 Product Type: Food & Beverages Ice Cream/Frozen Dairy Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: Ramar Foods Brand Name: Brand Name(s) Product Description: Product Description Mint Chocolate Chip with Hidden Spinach Ice…
Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use
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 Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters Model Numbers: Python Embolectomy Catheters: A4E01, A4E02, A4E03, A4E04, A4E05, A4E06, A4E08, A4E09 Bard Embolectomy…
Gresham Man Charged with Smuggling and Importing Misbranded Chloroquine from China for Attempted Resale
Department of JusticeU.S. Attorney’s OfficeDistrict of Oregon FOR IMMEDIATE RELEASEMonday, May 11, 2020 PORTLAND, Ore.—U.S. Attorney Billy J. Williams announced today that a Gresham, Oregon man has been charged with illegally purchasing, importing, and offering for sale chloroquine, the active pharmaceutical ingredient in prescription drugs used to treat malaria. Matthew Owens, 42, has been charged by…
Pair Sentenced for Conspiring to Defraud the Food and Drug Administration
Department of JusticeU.S. Attorney’s OfficeWestern District of Virginia FOR IMMEDIATE RELEASEThursday, May 7, 2020 Harrisonburg, Va. – A pair of former business partners who operated multiple websites selling drugs and other products to the bodybuilding community, were sentenced today in U.S. District Court in Harrisonburg on federal conspiracy charges. United States Attorney Thomas T. Cullen and…
UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Health Risk
Summary Company Announcement Date: May 11, 2020 FDA Publish Date: May 11, 2020 Product Type: Food & Beverages Vegetable Products Reason for Announcement: Recall Reason Description Contaminated by Cyclospora cayetanensis Company Name: United Natural Foods, Inc. Brand Name: Brand Name(s) Wild Harvest Product Description: Product Description Organic Fresh Basil Company Announcement United Natural Foods, Inc….
MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug
Summary Company Announcement Date: May 06, 2020 FDA Publish Date: May 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains undeclared minoxidil Company Name: MasterPharm, LLC Brand Name: Brand Name(s) MasterPharm, LLC Product Description: Product Description Finasteride Plus 1.25mg, capsules Company Announcement MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus…
Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) has become aware of the potential for health care facility staff that reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of medical devices because there is no standard indicator color to indicate a sterilized device. Health care facilities alerted the FDA that,…
Zilk’s Plus Resources Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Select 12 Oz Bottled Sauces
Summary Company Announcement Date: May 08, 2020 FDA Publish Date: May 08, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Allergens (Milk, Soy, and/or Wheat) Company Name: Zilk’s Plus Resources, LLC Brand Name: Brand Name(s) Pluckers World Famous Wing Sauce Product Description: Product Description Bottled Wing Sauces Company Announcement Zilk’s…