December 22, 2020
Adverse reactions or quality problems experienced with the use of a recalled product can be
reported to the FDA’s MedWatch Adverse Event Reporting
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December 22, 2020
December 22, 2020 – The U.S. FDA has approved an expanded indication for Vaxchora® (cholera vaccine,
live) oral suspension, manufactured by Emergent Travel Health. The vaccine, which
December 21, 2020
December 21, 2020 – The U.S. FDA has approved expanded indications for three medications from Vertex
Pharmaceuticals that are indicated to treat cystic fibrosis (CF), with patients selected
December 14, 2020
December 14, 2020 – The U.S. FDA has approved an additional, shorter infusion time for Ocrevus®
(ocrelizumab). Manufactured by Roche, the drug is indicated to treat adults who have
December 14, 2020
December 14, 2020 – The U.S. FDA has granted Emergency Use Authorization (EUA) to a vaccine from Pfizer and BioNTech to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals
December 11, 2020
December 11, 2020 - The U.S. Food and Drug Administration (FDA) granted Pfizer and BioNTech an
Emergency Use Authorization (EUA) for the companies’ jointly developed COVID-19 vaccine.
December 9, 2020
December 9, 2020 – AvKARE of Pulaski, TN, has voluntarily recalled one lot of Sildenafil 100mg tablets and
one lot of Trazodone 100mg tablets after the two products were inadvertently packaged
December 9, 2020
December 9, 2020 – Torrent Pharmaceuticals has voluntarily recalled one lot of Anagrelide Capsules, USP, following the product’s failure in a dissolution test that is part of routine quality testing.