New Delhi: Dr Reddy’s Laboratories on Wednesday confirmed it has recalled all ranitidine tablets from retail counters in the US due to the presence of the carcinogen N-nitrosodimethylamine (NDMA) above levels established by the US Food and Drug Administration (FDA).
The Hyderabad-based drug maker does not sell ranitidine in India.
Dr Reddy’s had initiated a voluntary recall of the medicine at the retail level for over-the-counter products and at the consumer level for prescription products on 1 October after the US FDA had issued a caution note alerting patients and health care professionals about the impurity in certain samples of ranitidine, the company said in an exchange filing.
While NDMA is a known environmental contaminant found in water and foods, it is also classified as a probable cancer-causing substance for humans based on results from laboratory tests.
On 13 September, the US Food and Drug Administration had issued a safety alert citing traces of NDMA in ranitidine.
Following the US regulator’s safety alert, the Drug Controller General of India also issued a directive to all state regulators asking them to get manufacturers to test anti-acidity drug ranitidine for the impurity.
On 25 September, GlaxoSmithKline Pharmaceuticals Ltd (GSK) suspended the distribution and supply of ranitidine hydrochloride products to all markets, including India, as a precautionary measure after regulatory authorities detected the carcinogen in its products.
The move by GSK followed suspension of the certificate of suitability of its bulk drug supplier Saraca Laboratories Ltd by the European Directorate for the Quality of Medicines (EDQM).
In India, GSK Pharma manufactures the drug under Zinetac. Other brands are JB Chemicals and Pharmaceuticals Ltd’s Rantac, Sun Pharmaceuticals Ltd's Histac, Torrent Pharmaceuticals Ltd's Ranitin, Ajanta Pharma Ltd's Pepitran.