Sandoz Inc. has voluntarily recalled 14 lots of prescription Ranitidine capsules due to exceeding the FDA’s limit of N-nitrosodimethylamine (NDMA) — a substance that could cause cancer.
The recalled Ranitidine capsules are an oral product used to decrease the amount of acid created by the stomach.
"OTC ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach," according to the U.S. Food and Drug Administration.< /span>
To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.
The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots, which were distributed nationwide to wholesalers:
|Product Name||NDC Number||Lot Number||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|
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the above products.
“We are continuing our investigation along with our international counterparts, and we will keep the American public informed of any additional recalls as well as the potential risks from taking ranitidine products,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30 a.m. – 5:00 p.m. Monday – Friday EST.