Drug Safety Alerts

Glenmark Ranitidine Consumer-Level Recall

12/17/2019

On December 17, 2019, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of all unexpired lots of Ranitidine 150 mg and 300 mg tablets manufactured by Glenmark. This recall was issued because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. Glenmark has stated that as of the date of its announcement, it has not received any reports of adverse events that have been confirmed to be directly related to this recall.

A list of the affected products is provided here:

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.

Glenmark’s Ranitidine Tablets 150 mg and 300 mg are manufactured at two manufacturing facilities. Of the 928 recalled lots of Ranitidine Tablets, USP, 16 lots were manufactured by Glenmark Pharmaceuticals Ltd., Goa, India and 912 lots were manufactured by Strides Pharma Science Limited, Puducherry, India. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The affected Ranitidine Tablets were distributed directly to Wholesalers, Distributors, Retailers and Repackagers nationwide.

Patients using the recalled product have been advised to discontinue the product and call their providers for alternative treatment options.

CVS Caremark Response: Because of this action, CVS Caremark® Mail Service Pharmacy is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.

For more information about this recall, please contact Qualanex at 1-888-504-2012 or visit https://glenmarkpharma-us.com.

You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.