lunes, 4 de marzo de 2019

Drug Safety and Availability > FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan

Drug Safety and Availability > FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan



An Update to Three Recent MedWatch Safety Alert Recalls: on Angiotensin II Receptor Blocker Including Valsartan and Losartan.

  • Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide Tablets by Torrent Pharmaceuticals Limited: Recall - Due to the Detection of Trace Amounts of N-Methylnitrosobutyric Acid Found in an Active Pharmaceutical Ingredient (API) (03/01/19)
  • Amlodipine Valsartan Tablets and Valsartan Tablets by AurobindoPharma USA: Recall - Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity (03/01/19)
  • Losartan Potassium Tablets by Camber Pharmaceuticals: Recall - Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino Butyric Acid (NMBA) Impurity Found in the API (02/28/19)

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