Glenmark Joins Sanofi, GSK and Others in Recall of Ranitidine Products
Another recall has been issued for ranitidine tablets due to the presence of a carcinogen contaminant.
This morning, Glenmark Pharmaceuticals, USA, announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg. The company issued the recall due to the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the U.S. Food and Drug Administration.
Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Glenmark’s ranitidine products are prescription medications approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. In its brief announcement, Glenmark said it has not received any reports of adverse events that have been confirmed to be directly related to this recall.
The Glenmark recall marks the latest in a series of companies recalling ranitidine medications due to the presence of NDMA, a carcinogen. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables. In large amounts, NDMA can cause health problems. The FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine).
With the recall, Glenmark joins Aurobindo Pharma USA, Sanofi, GlaxoSmithKline, Novartis, Dr. Reddy’s Laboratories, Perrigo, Novitium Pharma and Lannett Company. Following the wave of ranitidine recalls that began with Sanofi’s Zantac, the FDA released a list of ranitidine medications that have been found to be free of NDMA. In October, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing.
Glenmark’s ranitidine tablets are manufactured at two approved manufacturing facilities, one owned by the company in Goa, India and the other owned by Strides Pharma Science Limited in Puducherry, India.
For the 150 mg tablets, the drug codes being recalled are 684620-248-60, 684620-248-01 and 684620-248-05. The 300 mg tablets being recalled have drug codes of 684620-249-30, 684620-249-01 and 684620-249-20. The tablets all have expiration date ranges of December of this year through June of 2022.
Glenmark said in its announcement that it is committed to safety and will fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Glenmark ceased distribution of its ranitidine products in the United States while it continues its efforts to test and investigate in cooperation with the FDA.