Dr Reddy’s recalls Ranitidine from US market

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Published: October 24, 2019 1:44:48 AM

OTC ranitidine products are mainly used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

The Drug Controller General of India (DGCI) has reportedly asked state drug departments to ensure that ranitidine is sold only under prescription.

Dr Reddy’s Laboratories (DRL) on Wednesday said it had commenced voluntary recall of all its medications containing the active ingredient ranitidine from the US market, effective October 1. The move is in sync with similar recalls of branded and generic versions of the popular heartburn drug by major drugstore chains in the US, following an FDA caution note alerting patients and healthcare professionals of presence of low levels of N-nitrosodimethylamine (NDMA), a human carcinogen, in ranitidine formulations.

“All ranitidine products with expiration dated September 2019 to June 2021 are being recalled,” DRL said. Ranitidine, which belongs to a group of drugs called histamine-2 blockers, works by reducing the amount of acid stomach produces and is used to treat and prevent ulcers in the stomach and intestines and manage several other conditions like GERD and Zollinger-Ellison syndrome. It is also there on the WHO’s list of essential medicines.

Indian drug authorities are reportedly undertaking a review of ranitidine in the wake of the USFDA move. The Drug Controller General of India (DGCI) has reportedly asked state drug departments to ensure that ranitidine is sold only under prescription.

The market for ranitidine formulations in India is worth about Rs 700 crore at present. To date, DRL has not received any reports of adverse events related to its ranitidine products, the company said. The recall includes all quantities in the US that are within expiry, it added.

OTC ranitidine products are mainly used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

According to reports, on September 13, 2019, the USFDA announced that its preliminary tests found low levels of NDMA in ranitidine. MNC drug companies Novartis (through its generic division, Sandoz) and Apotex had earlier announced that they were recalling all of their generic ranitidine products sold in the US.

While the USFDA and the European drug regulators alerted patients on the safety issue of ranitidine, Bangladesh has recently banned the drug’s sale.

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