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:…

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….

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…

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…

Natural Remedy Store Issues Voluntary Worldwide – Recall of Active Male Due to Presence of Undeclared Tadalafil

Summary Company Announcement Date: March 16, 2020 FDA Publish Date: March 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Undeclared Tadalafil Company Name: Natural Remedy Store Brand Name: Brand Name(s) Natural Remedies Product Description: Product Description Active Male capsules Company Announcement Natural Remedy Store is voluntarily recalling all lots of…