Important recall notice: 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 Name	NDC Number	Lot Nbr.	Expiration Date	Date of Manufacture
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HD1862	04/30/2020	04/19/2017
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HP9438	09/30/2020	09/05/2017
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HP9439	09/30/2020	09/06/2017
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HP9440	09/30/2020	09/05/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	HC9266	04/30/2020	04/19/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	HD1865	04/30/2020	04/19/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	HP9441	09/30/2020	09/06/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	JK7994	08/31/2021	08/07/2018
RANITIDINE 150mg Capsules 60 count	0781-2855-60	JK8659	08/31/2021	08/07/2018
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HD8625	04/30/2020	04/27/2017
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HD9275	04/30/2020	04/27/2017
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HU2207	08/31/2020	08/24/2017
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HX6676	03/31/2021	03/20/2018
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HX6677	03/31/2021	03/20/2018

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: 08 de Diciembre del 2023