Dr. Reddy’s confirms its voluntary nationwide recall of all Ranitidine products in the U.S. Market
Dr. Reddy’s Laboratories Ltd. confirms 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 due to confirmed contamination with NNitrosodimethylamine (NDMA) above levels established by the FDA. This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine. 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 that are within expiry.
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. Over-the-counter (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.
Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine
As a precautionary measure, Perrigo Company plc announced that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
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 an over-the-counter (OTC) and prescription product indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.
After regulatory bodies announced that ranitidine may potentially contain NDMA, Perrigo promptly began testing of its externally sourced ranitidine API (active pharmaceutical ingredient) and ranitidine-based products. On October 8, 2019, Perrigo halted shipments of the product based upon preliminary results. Based on the totality of data gathered to date, Perrigo has made the decision to conduct this voluntary recall.
Perrigo has the highest commitment to consumer safety and will continue to communicate ongoing testing results with health authorities. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Perrigo is notifying our retail customers by phone, email or other communication with recall notification communications to arrange for the return of all recalled product.