Heartburn Medication Recall 2019: Another 928 Lots Of Ranitidine Recalled For Cancer-Causing Ingredient

Following several recalls for the heartburn medication ranitidine, another pharmaceutical company has issued a recall for the drug for a cancer-causing impurity. Glenmark Pharmaceuticals Inc. (GLENMARK.NS) has recalled 928 lots of 150 and 300 mg ranitidine tablets.

The recalled medication may have N-nitrosodimethylamine (NDMA) – a cancer-causing ingredient – above the acceptable daily levels established by the U.S. Food & Drug Administration (FDA).

Ranitidine is used in the treatment and prevention of stomach and intestine ulcers as well as for gastroesophageal reflux disease. Glenmark’s ranitidine tablets are a prescription-only oral medication.

The affected ranitidine tablets were manufactured at two approved facilities in Goa and Puducherry, India, and distributed by wholesalers, distributors, retailers, and repackagers nationwide. The 150 mg ranitidine tablets were packaged in 60, 100, and 500 count bottle packs while the 300 mg ranitidine tablets were packaged in 30, 100, and 250 count bottle packs.

The recalled medication can be identified by the NDC number located on the bottle. A full list of the 928 lots being recalled can be viewed here. Labels of the recalled medication can be viewed here.

Consumers taking the recalled medication should discontinue its use immediately and consult their physician for an alternative treatment plan. Individuals that experience adverse reactions from the recalled tablets should contact their healthcare provider.

To return the medication, consumers can call Qualanex at 1-888-504-2012, Monday through Friday from 9 a.m. to 5 p.m. EST. Adverse reactions from the recalled medication can be directed to Glenmark’s Drug Safety customer service center at 1-888-721-7115, Monday through Friday from 9 a.m. to 6 p.m. EST or by email at GlobalCustomerService@glenmarkpharma.com.

Glenmark has ceased all distribution of the affected heartburn medication in the U.S. The company has not received any reports of adverse reactions due to the recalled heartburn medication. It did say that it is “committed to product and consumer safety” and is fully cooperating with the FDA in the evaluation of the product.

Shares of Glenmark stock were up 2.22% as of 9:42 a.m. EST on Wednesday.