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Drug Companies Issue Recalls For Ranitidine, Zantac In US

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Drug companies in the U.S. have started issuing recalls for heartburn medication Ranitidine, sold under the trade name Zantac among others, on confirmation of contamination with N-Nitrosodimethylamine or NDMA above levels established by the U.S. Food and Drug Administration or FDA.

The move follows a public statement issued by the FDA on September 13, alerting that some Ranitidine medicines, including Zantac over-the-counter or OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. NDMA was found by the FDA in certain samples of Ranitidine.

NDMA, a known environmental contaminant, is classified as a probable human carcinogen. These are generally found in water and foods, including meats, dairy products, and vegetables.

Prescription Ranitidine, a histamine-2 blocker, is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastro-esophageal reflux disease.

Ranitidine is available as an OTC and prescription drug. It is used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

Dr. Reddy's Laboratories Ltd. issued a recall earlier in the month for all of its Ranitidine medications sold in U.S. with expiration dated September 2019 to June 2021. However, Dr. Reddy's has not received any reports of adverse events to date related to the recall of Dr. Reddy's Ranitidine products.

Dr. Reddy's recall primarily involves 33 lots of Ranitidine Hydrochloride tablets and capsules 75 mg, 150 mg and 300 mg of 24, 30, 40, 50, 60, 65, 80, 95, 100, 130, 160, 190, 200, 220 and 500 count bottles or tray.

Perrigo Co. plc also issued a worldwide product recall to the retail customer level of all pack sizes of Ranitidine on Wednesday.

Last week, Sanofi recalled of all Zantac OTC in the U.S., including Zantac 150, Zantac 150 Cool Mint, and Zantac 75 for similar contamination issues.

On September 25, Apotex Corp., on a precautionary basis, recalled Ranitidine Tablets 75 mg and 150 mg of all pack sizes and formats to the retail level.

In late September, pharma firm Sandoz Inc., the generics division of Swiss drug maker Novartis AG, also issued a recall for prescription Ranitidine capsules, involving 14 lots of Ranitidine Hydrochloride capsules 150 mg and 300 mg of 30 count, 60 count and 500 count bottles.

These were manufactured between April 2017 and August 2018, with expiration dates between April 2020 and August 2021.

Walmart, Walgreens and CVS Pharmacy recently announced that they would stop sales of Ranitidine medications at their counters due to impurity concerns.

The FDA has also been investigating NDMA and other Nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers or ARBs since last year.

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