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:…

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…

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…

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…