In another industry recall of ranitidine products, Glenmark Pharmaceutical Inc. USA announced on December 17, 2019, a voluntary recall of all unexpired lots of ranitidine tablets, 150 mg and 300 mg, to the consumer level because of the presence or potential presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake levels established by the US Food and Drug Administration (FDA). Ranitidine is a histamine-2 blocker that decreases the amount of acid created by the stomach.

To date (as of December 17, 2019), Glenmark says it has not received any reports of adverse events that have been confirmed to be directly related to this recall. The affected ranitidine tablets were distributed directly to wholesalers, distributors, retailers and repackagers nationwide in the US.

Glenmark’s ranitidine tablets, 150 mg and 300 mg, are manufactured at two approved 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, are prescription oral products approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

Glenmark said it “will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers,” in a December 17, 2019 statement. As a further precautionary measure, Glenmark said it ceased distribution of its ranitidine products in the US while it continues its efforts to test and investigate in cooperation with the FDA.

The recall by Glenmark is the latest recall of ranitidine products, both prescription and over-the-counter products, by drug manufacturers, which began last year (2019). Several companies, including Sanofi, Dr. Reddy’s Laboratories, Teva Pharmaceutical, and GlaxoSmithKline initiated voluntary recalls of ranitidine products, due to the actual or potential of nitrosamine impurities. Both the FDA and the European Medicines Agency initiated investigations of the impurities in ranitidine products in 2019. This followed earlier product recalls and investigations in 2018 and 2019 of nitrosamine impurities in “sartan”-containing active pharmaceutical ingredients used in anti-hypertensive and cardiovascular drugs, such as valsartan, candesartan, irbesartan, losartan, and olmesartan.

Source: Glenmark Pharmaceuticals and FDA