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: 13 de marzo del 2020