Image Español At the U.S. Food and Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best science available. The FDA’s complex and multifaceted mission includes evaluating new medicines, including vaccines and other therapies, to determine if they are safe and effective for their intended use….
Consejos de seguridad para el Día de las Brujas: disfraces, dulces, lentes de colores
Image English Ya sea que se disfrace de fantasma o zombie, vampiro o bruja, las malas elecciones de disfraces, incluyendo los lentes de contacto decorativos (de colores) y disfraces inflamables, y las alergias causadas por pinturas faciales, pueden causar daños que los mantendrá asustados por mucho tiempo después del Día de las Brujas (Halloween). Disfrute un Día de…
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication – Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. For prescription NSAIDs, FDA is requiring changes to…
Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing – Letter to Health Care Providers
October 7, 2020 The U.S. Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the…
Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: October 02, 2020 FDA Publish Date: October 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Marksans Pharma Limited Brand Name: Brand Name(s) Time-Cap Labs Inc. Product Description: Product Description Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and…
Es un buen momento para vacunarse contra la influenza
Image English Aunque los Estados Unidos sigue centrado en la pandemia del COVID-19, también necesitamos ser conscientes de la temporada de la influenza a medida que nos acercamos al invierno. Los virus de la influenza (gripe) generalmente se propagan en otoño e invierno, y su actividad alcanza su punto máximo entre diciembre y febrero. Vacunarse…
Ashtel Studios Issues Voluntary Recall of Licensed Hand Sanitizers Packaged in 0.84 Fluid Ounce Pouches Due to Misbranding Because They Resemble Food and Drink Container Pouches
Summary Company Announcement Date: October 01, 2020 FDA Publish Date: October 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is packaged in containers resembling a food and drink pouch Company Name: Ashtel Studios Brand Name: Brand Name(s) Smart Care Product Description: Product Description Hand sanitizer packaged in 0.84 oz. pouches Company…
Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys
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 BD Alaris Pump Module and Pump Module Door Assembly Replacement Kits Affected Models: Model 8100 (Pump Module) Pump Module Door Assembly Replacement Kits, Part Numbers: 49000346 49000239…
The Facts on Tampons—and How to Use Them Safely
Image CaptionTampons—shown within an applicator on the left and without an applicator on the right—are regulated by the U.S. Food and Drug Administration as medical devices. Español If you use tampons during your period (or menstruation), it’s important to know how to use them safely. Consider this important information from the U.S. Food and Drug…
Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including public health partners, manufacturers, and experts to evaluate additional strategies to reduce the risk of infection from using these devices during cardiac…