Granules recalls over 2.3 cr Ranitidine tablets from US
City-based pharma player Granules India Ltd has initiated a voluntary recall of over 2.3 crore tablets of Ranitidine 150 mg in the US market because of the presence of carcinogen N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API) used for making the anti-acidity medicine.
Granules India has recalled the Ranitidine tablets citing “CGMP deviations: impurity NDMA found in API” as the reason for the recall.
The recall, which was initiated on December 13, 2019, and is ongoing, has been classified as `Class II’, the US drug watchdog, US Food & Drug Administration (USFDA) said in the latest enforcement report uploaded on its website.
USFDA classifies a Class II recall as one in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In such a recall the firm removes the product from the market or corrects the violation, as per the USFDA website.Granules had received approval for its abbreviated new drug application (ANDA) for Ranitidine 150mg from the USFDA in mid 2018.
The US drug regulator had, in September 2019, sounded an alert on the presence of NDMA, classified as a probable human carcinogen, in some Ranitidine medicines. NDMA is a known environmental contaminant that is found in water and foods, including meats, dairy products and vegetables.
USFDA had advised companies to recall their Ranitidine products if testing showed levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million).
Since then, several pharma companies including Hyderabad-based players like Dr Reddy’s Laboratories and Aurobindo Pharma have initiated voluntary recall of Ranitidine from the US market. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.