December 18, 2019
Glenmark Pharmaceuticals has halted distribution of both its 150mg and 300mg prescription ranitidine tablets due to the potential for N-nitrosodimethylamine (NDMA) levels in excess of the FDA’s currently established limits. The company has also recalled all unexpired lots on the United States market.
NDMA is considered a probable human carcinogen, or a substance with the potential to cause cancer. The substance is found in the environment, including certain water and food supplies, and has been a source of concern for ranitidine manufacturers since September 2019, when a pharmacy alerted the FDA to NDMA present in samples of ranitidine products. Since then, multiple manufacturers have recalled both prescription and over-the-counter ranitidine. In some cases, manufacturers have halted production and distribution as well.
The FDA does not believe the amount of NDMA found in ranitidine products to date represents an immediate threat to consumers. The agency has advised patients to speak to their physician or pharmacist about switching to another medication if they are concerned about taking ranitidine. Many medications available in the U.S. are FDA-approved for the same or similar indications as ranitidine, which is used to treat certain gastrointestinal conditions.
Additional details regarding NDMA in ranitidine and the current status of drug recalls can be found at the FDA’s website. Return instructions for the recalled Glenmark products are available on the site as well. Benecard’s Mail Order Pharmacy, Benecard Central Fill has not dispensed any of the recalled product.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.