Ranitidine capsule recall - Sandoz Inc.

September 24, 2019

On September 23, 2019, Sandoz, Inc. announced issued a voluntary recall of Ranitidine 150mg capsules, and 300mg capsules due to an elevated amount of an unexpected impurity (NDMA) found in the active pharmaceutical ingredient.

Product Name	NDC Number	Lot Nbr.	Expiration Date	Date of Manufacture
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HD1862	4/30/2020	4/19/2017
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HP9438	9/30/2020	9/5/2017
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HP9439	9/30/2020	9/6/2017
RANITIDINE 150mg Capsules 500 count	0781-2855-05	HP9440	9/30/2020	9/5/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	HC9266	4/30/2020	4/19/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	HD1865	4/30/2020	4/19/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	HP9441	9/30/2020	9/6/2017
RANITIDINE 150mg Capsules 60 count	0781-2855-60	JK7994	8/31/2021	8/7/2018
RANITIDINE 150mg Capsules 60 count	0781-2855-60	JK8659	8/31/2021	8/7/2018
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HD8625	4/30/2020	4/27/2017
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HD9275	4/30/2020	4/27/2017
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HU2207	8/31/2020	8/24/2017
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HX6676	3/31/2021	3/20/2018
RANITIDINE 300mg Capsules 30 count	0781-2865-31	HX6677	3/31/2021	3/20/2018

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

Last updated: March 13, 2020

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