Pharma major Dr. Reddy’s Laboratories is recalling all of its ranitidine medications sold in the U.S. due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above the levels established by the U.S. Food and Drug Administration (USFDA).
The recall includes all quantities in the U.S. that are within expiry.
Ranitidine is available as an over-the-counter (OTC) and prescription drug. The OTC tablets are used to relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine capsules are prescribed for the short-term treatment of active duodenal ulcer, active, benign gastric ulcer as well of gastroesophageal reflux disease.
Stating it is confirming the voluntary, nationwide recall in the U.S., the company on Wednesday said the recall was initiated on October 1 (at the retail level for over-the-counter products and at the consumer level for prescription products).
A statement from Dr.Reddy’s said the recall follows the USFDA’s caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine. The company said NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
All ranitidine products with expiration dated September 2019 to June 2021 are being recalled, the company said.
