Summary Company Announcement Date: January 08, 2020 FDA Publish Date: January 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Mylan N.V. Brand Name: Brand Name(s) Product Description: Product Description Nizatidine Capsules 150mg and 300mg Company Announcement Mylan N.V.(NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals…
Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
Summary Company Announcement Date: January 10, 2020 FDA Publish Date: January 10, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Cross contamination with another drug substance, Enalapril Maleate Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals Product Description: Product Description Lamotrigine Tablets, USP 100mg Company Announcement Taro Pharmaceuticals U.S.A.,…
Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator
Summary Company Announcement Date: December 27, 2019 FDA Publish Date: January 10, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Failure to deliver a defibrillation shock after the “Shock” button on the keypad is pressed Company Name: Stryker Brand Name: Brand Name(s) LIFEPAK 15 Product Description: Product Description LIFEPAK 15 monitor/defibrillators Company…
Algunos medicamentos para dormir pueden afectar su capacidad para conducir
English Muchas personas toman sedantes para poder dormir. La Administración de Alimentos y Medicamentos (FDA) recuerda a los consumidores que algunos medicamentos para tratar el insomnio pueden reducir su capacidad de estar alerta a la mañana siguiente de su uso, afectado sus habilidades para realizar funciones en los que se debe estar muy alerta, como…
Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination
Summary Company Announcement Date: December 23, 2019 FDA Publish Date: January 08, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Burkholderia cepacia Company Name: Mavidon Brand Name: Brand Name(s) LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep Product Description: Product Description LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep…
No tome dosis doble de acetaminofén
La FDA es miembro de la Coalición de Concientización Acetaminofén (AAC en inglés), un grupo diverso de líderes en salud y organizaciones de consumidores. La campaña de educación de AAC, “Double Check, Don’t Doble Up” aborda el tema del consumo se seguro de acetaminofén para más información visite: www.knowyourdose.org (información disponible en español) English Usted…
Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: January 06, 2020 FDA Publish Date: January 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Denton Pharma, Inc. dba Northwind Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Denton Pharma, Inc. dba Northwind Pharmaceuticals, an…
FDA Criminal Unit Guards Public Health
When it comes to protecting the public, most people think of their local fire, police, and sheriff’s departments, state troopers, and the FBI. What’s less known is that the Food and Drug Administration (FDA) also has a team of criminal investigators—called special agents—who are protecting public health as part of the Office of Criminal Investigations…
Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: January 07, 2020 FDA Publish Date: January 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: Appco Pharma LLC Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Tablets 150mg and 300mg Company Announcement Appco Pharma LLC (Appco) is voluntarily recalling all quantities and…
Practice Hospital Bed Safety
Hospital Bed Entrapment Zones An FDA guidance characterizes the head, neck, and chest as key body parts at risk of entrapment, and identifies seven potential “zones of entrapment” where special care is required: 1. within the rail 2. under the rail, between the rail supports or next to a single rail support 3. between the…