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…
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…
CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion
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 CME America BodyGuard Microset Infusion Sets All Lots of affected Catalog Number Catalog Number: A120-003XYVA Distribution Dates: October 6, 2017 – July 15, 2019 Devices Recalled in…
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…