Sandoz is recalling all quantities and lots within of Ranitidine Hydrochloride Capsules in the US.
The products are contaminated with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.
NDMA is classified as a probable substance that could cause cancer.
The firm says it has not received any reports of adverse events to date.
The following lots of the product, including 30-count, 60-count and 500-count bottles, are being recalled:
|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|
The recalled product can be identified by the NDC number and lot number provided above.
What to do
Customers who purchased the recalled product should continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.
Consumers with questions may contact Sandoz at (800) 525-8747 option # between 8:30am – 5:00pm Monday – Friday (EST) or online at www.us.sandoz.com for more information.
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