Fecal Microbiota for Transplantation: Safety Alert – Regarding Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19

[Posted 03/23/2020] AUDIENCE: Patient, Health Professional ISSUE: FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) and that FDA has determined that additional safety protections are needed. Several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid…

Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Image While many Americans are sheltering at home to help “flatten the curve” and slow the spread of coronavirus disease (also called COVID-19), they might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent COVID-19. Because COVID-19 has never been seen in humans before, there are…

Guan’s Mushroom Co Recalls Enoki Because of Possible Health Risk

Summary Company Announcement Date: March 23, 2020 FDA Publish Date: March 23, 2020 Product Type: Food & BeveragesFoodborne Illness Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes Company Name: Guan’s Mushroom Co. Brand Name: Brand Name(s) Guan’s Mushroom Co. Product Description: Product Description Enoki Mushroom Company Announcement Guan’s Mushroom Co of Commerce, CA is…

IcelandicPlus LLC Voluntarily Recalls Whole Capelin Fish Pet Treats Because Product Exceeds FDA Size Restrictions

Summary Company Announcement Date: March 19, 2020 FDA Publish Date: March 23, 2020 Product Type: Animal & VeterinaryFood & BeveragesPet FoodFoodborne Illness Reason for Announcement: Recall Reason Description Potential for Clostridium botulinum Company Name: IcelandicPlus LLC Brand Name: Brand Name(s) Icelandic+ Product Description: Product Description Whole Capelin Fish Pet Treats Company Announcement Out of an…

Biosimilar and Interchangeable Biologics: More Treatment Choices

[embedded content] The U.S. Food and Drug Administration (FDA) has approved biosimilar medications to treat conditions such as cancer, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more. But what are biosimilar and interchangeable biological medications? To answer that question, it helps to first know what biological products (biologics) are. Biologics: Medications From Living Organisms Biologics…

Ventilator Supply Mitigation Strategies: Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) recognizes that the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities during the Coronavirus Disease 2019 (COVID-19) outbreak. On March 22, 2020, the FDA issued an immediately in effect guidance outlining a policy intended to help increase availability…

Medical Glove Conservation Strategies: Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) recognizes the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak. This Letter to Health Care Providers refers specifically to potential shortages relating to surgeons’ gloves and patient examination gloves. The…

Lindt & Sprüngli (USA) Inc. Issues Voluntary Recall on Undeclared Milk and Soy in One Lot of Lindt Excellence 85% Cocoa Chocolate Bars

Summary Company Announcement Date: March 19, 2020 FDA Publish Date: March 20, 2020 Product Type: Food & BeveragesAllergens Reason for Announcement: Recall Reason Description Undeclared milk and soy Company Name: Lindt & Sprüngli Brand Name: Brand Name(s) Product Description: Product Description 85% Cocoa chocolate bars Company Announcement Lindt & Sprüngli (USA) Inc. of Stratham, New…

Mountain Rose Herbs Recalls Organic Kudzu Root Herbal Supplement Due to Possible Health Risk

Summary Company Announcement Date: March 18, 2020 FDA Publish Date: March 18, 2020 Product Type: Dietary SupplementsFood & BeveragesHerbalFoodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Mountain Rose Herbs Brand Name: Brand Name(s) Mountain Rose Herbs Product Description: Product Description Organic Kudzu Root Herbal Supplement Company Announcement…