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 Rashkind Balloon Septostomy Catheter Lot Numbers: See the Recall database entries below for lot numbers Product Numbers: 008764, 007160, and 007161 Distribution Dates: May 28, 2018 to…
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 03, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 500 mg Company Announcement Nostrum Laboratories, Inc….
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2…
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: November 02, 2020 FDA Publish Date: November 02, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 750 mg Company Announcement Kansas City, Missouri,…
Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy
Image Español To survive, we need oxygen going from our lungs to the cells in our body. Sometimes the amount of oxygen in our blood can fall below normal levels. Asthma, lung cancer, chronic obstructive pulmonary disease (COPD), the flu, and COVID-19 are some of the health issues that may cause oxygen levels to drop….
Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)
Summary Company Announcement Date: October 28, 2020 FDA Publish Date: October 29, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Deviations from the specified cleaning methods may impair infusion pump Company Name: Baxter International Inc. Brand Name: Brand Name(s) Sigma Spectrum Product Description: Product Description Infusion Pumps Company Announcement Baxter International Inc….
Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
Summary Company Announcement Date: October 27, 2020 FDA Publish Date: October 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Sunstar Americas, Inc. Brand Name: Brand Name(s) Product Description: Product Description Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz Company Announcement Sunstar Americas, Inc….
Breast Cancer Screening: Thermogram No Substitute for Mammogram
Image CaptionA mammogram (left) is an X-ray of the breast which, in this case, shows a cancerous mass in white. Thermography (right) produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body. Español The U.S. Food and Drug Administration is reminding you that mammography—a…
Prueba de detección del cáncer de seno: La termografía no sustituye la mamografía
Image CaptionUna mamografía (a la izquierda) es una radiografía del pecho que, en este caso, muestra la masa cancerígena como de color blanco. La termografía (a la izquierda) genera una imagen infrarroja que muestra los patrones de calor y flujo sanguíneo en o cerca d English La Administración de Alimentos y Medicamentos de los Estados…
Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses
Image Español Halloween is fast approaching, and you and your kids may be celebrating it a bit differently this year. Whatever form your celebration takes, make sure it includes safe hygiene practices such as covering your mouth and nose with a cloth face covering or mask when around others, maintaining social distance and frequent hand washing. The…