Hyderabad, Oct 23 : Dr. Reddy’s Laboratories Limited on Wednesday confirmed it had initiated a voluntary nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US market due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.
Dr. Reddy’s Ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration dated September 2019 to June 2021 are being recalled. This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine, Hyderabad-based pharmaceutical company said in a release here.
To date, Dr. Reddy’s has not received any reports of adverse events related to the recall of Dr. Reddy’s Ranitidine products. The recall includes all quantities in the US market that are within expiry.
In its Risk Statement, NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranitidine is available as an over-the-counter (OTC) and prescription drug and OTC ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach.
OTC Ranitidine Tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. Prescription ranitidine capsules are prescribed for the short-term treatment of active duodenal ulcer; maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers; treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); short-term treatment of active, benign gastric ulcer; maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers; treatment of GERD (Gastroesophageal reflux disease); treatment of endoscopically diagnosed erosive esophagitis; and for maintenance of healing of erosive esophagitis. (UNI)