fbpx
February 11, 2021

Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a […]
February 11, 2021

More Questions and Answers: Impurities Found in Certain Angiotensin II Receptor Blocker (ARB) products

We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities. Manufacturers are required to test for impurities that may be introduced […]
February 11, 2021

Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan

A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Valsartan 80mg Tablet 54569-6582-1  342B17019 09/2019 A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Valsartan 80mg Tablet 54569-6582-1  342B17018 08/2019 […]
February 11, 2021

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Update [7/27/2018] On July 13th, FDA announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). Valsartan […]
February 11, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Pradaxa (dabigatrán etexilato mesilato) no se debe usar en pacientes con válvulas protésicas del corazón

Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datos Anuncio de seguridad El 19 de diciembre del 2012, La Administración de […]
February 11, 2021

Annual Reports

FDA’s Office of Generic Drugs (OGD) reports annually on its accomplishments and organization. The reports include a Director’s Message summarizing the year’s activities, data on improved efficiency […]
February 10, 2021

Prescription Drug User Fee Amendments

When are user fees due? An application fee is due when the application is submitted to FDA. FDA issues invoices for annual program fees for the […]
February 10, 2021

Drug Shortages: Non-Compliance With Notification Requirement

Under section 506C of the Federal Food, Drug, and Cosmetic Act, manufacturers of all covered prescription drugs are required to notify FDA of a permanent discontinuance […]
February 10, 2021

EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine

Summary Company Announcement Date: July 24, 2017 FDA Publish Date: February 08, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0