Ranitidine recall – Sandoz Inc.

30 de octubre del 2019

On September 23, 2019, Sandoz, Inc. announced issued a voluntary recall of all lots of Ranitidine capsules due to an elevated amount of an unexpected impurity (NDMA) found in the active pharmaceutical ingredient.

Express Scripts will mail letters to patients who have received medication impacted by the recall.

The FDA recommends speaking with your prescriber if you want to stop your medication or use an alternative medication.

Product NameNDC NumberLot Nbr.Expiration DateDate of Manufacture
RANITIDINE 150mg Capsules 500 count0781-2855-05HD186204/30/202004/19/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP943809/30/202009/05/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP943909/30/202009/06/2017
RANITIDINE 150mg Capsules 500 count0781-2855-05HP944009/30/202009/05/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HC926604/30/202004/19/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HD186504/30/202004/19/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60HP944109/30/202009/06/2017
RANITIDINE 150mg Capsules 60 count0781-2855-60JK799408/31/202108/07/2018
RANITIDINE 150mg Capsules 60 count0781-2855-60JK865908/31/202108/07/2018
RANITIDINE 300mg Capsules 30 count0781-2865-31HD862504/30/202004/27/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HD927504/30/202004/27/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HU220708/31/202008/24/2017
RANITIDINE 300mg Capsules 30 count0781-2865-31HX667603/31/202103/20/2018
RANITIDINE 300mg Capsules 30 count0781-2865-31HX667703/31/202103/20/2018

Additional information is available on the FDA’s website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated

Última actualización: 13 de marzo del 2020