Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: June 26, 2020 FDA Publish Date: June 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description May contain methanol (wood alcohol) Company Name: Saniderm Products Brand Name: Brand Name(s) Product Description: Product Description Advanced Hand Sanitizer Company Announcement Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged…

Facts About In-Home HIV Testing

Image Español It’s estimated that 1.1 million people in the U.S. are living with HIV. And some of those people — about one in seven — don’t know they have it, according to the U.S. Centers for Disease Control and Prevention (CDC). HIV screening is key to controlling the virus. If people can’t get to…

Getting Smarter about Food Safety: The Pandemic and Lessons Learned

Image Throughout the COVID-19 pandemic, the experts at the U.S. Food and Drug Administration have learned valuable lessons that will help shape our work to create a more digital, transparent and safer food system for you and your family. In the coming weeks, the FDA will be rolling out the blueprint for the New Era of…

Do Not Use Infant Sleep Positioners Due to the Risk of Suffocation

[embedded content] Español The U.S. Food and Drug Administration is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death. The FDA regulates baby products as medical devices if, among other things, the manufacturer claims…

Lupus Therapies Continue to Evolve

Sources: U.S. Food and Drug Administration (FDA) and American College of Rheumatology Español It can be a difficult disease to diagnose and a difficult disease to treat. It’s called lupus, and as many as 24,000 people in the United States are diagnosed with the disease each year. May is National Lupus Awareness month, a time…

First Rapid Home-Use HIV Kit Approved for Self-Testing

Image Español On July 3, 2012 the Food and Drug Administration (FDA) approved the OraQuick In-Home HIV Test, a rapid home-use HIV test kit that does not require sending a sample to a laboratory for analysis. The kit provides a test result in 20-40 minutes, and you can test yourself in your own home. The…

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

Summary Company Announcement Date: June 18, 2020 FDA Publish Date: June 18, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Incorrect dosing cups Company Name: GSK Consumer Healthcare Brand Name: Brand Name(s) Robitussin Product Description: Product Description Cough and cold products Company Announcement GSK Consumer Healthcare is voluntarily recalling to the…

Primera prueba rápida casera de autoexamen para el VIH aprobada

Image English La Administración de Alimentos y Medicamentos (FDA en inglés) ha aprobado OraQuick Prueba Casera para el VIH, una prueba rápida de uso en casa pare el VIH que no requiere enviar una muestra a un laboratorio para su análisis. La prueba proporciona un resultado en 20 a 40 minutos, y usted puede hacerse…

Certain COVID-19 Serology/Antibody Tests Should Not Be Used – Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage.  The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or…