Glenmark Pharmaceuticals, an India-based drugmaker, recalled all unexpired lots of its 150 mg and 300 mg ranitidine tablets Dec. 17 after finding the products may contain a human carcinogen.
The recalled products were either proven to contain or had the potential to contain N-nitrosodimethylamine, or NDMA, a human carcinogen, above the FDA-approved level.
Glenmark also ceased all distribution of its ranitidine products in the U.S. while it continues to test its products.
The recalled drugs were distributed nationwide to wholesalers, distributors and retailers.
Consumers with the recalled products should immediately discontinue use and consult with a physician about treatment options.
To date, Glenmark said it has not received any adverse event reports related to the recall.
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