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New FDA Statement on NDMA Impurities in Drug Products

New FDA Statement on NDMA Impurities in Drug Products

FDA published a statement on September 13, 2019 concerning a nitrosamine impurity in some ranitidine (brand name Zantac) medicines.  The impurity is called N-nitrosodimethylamine (NDMA). The FDA has been investigating NDMA in certain heart medications, Angiotensin II Receptor Blockers (ARB’s), since 2018. In June 2018, US manufacturer Prinston Laboratories Inc. contacted FDA about its valsartan-containing product from API manufacturer Zhejiang Huahai Pharmaceuticals Co. (ZHP) due to NDMA found by ZHP.

What is NDMA?

NDMA is an environmental contaminant found in water and foods, including meat, dairy products, and vegetables. Although it is classified as a probable human carcinogen, based on laboratory test, it does not pose an immediate health risk at low levels. NDMA may cause cancer only after prolonged exposure to high doses.

What Should Patients Do?

While the ranitidine statement warns patients of the possible impurity, they are urged to continue taking their medication, as the benefit from the drug outweighs the risk to NDMA to their health. The source of the impurity is being investigated.

Testing Drug Products for NDMA

The FDA-published method for determination of NDMA using GC-MS/MS has been observed to elevate NDMA levels, due to the formation of NDMA at elevated temperatures. FDA, therefore, published another method, this one using liquid chromatography with high resolution mass spectrometer (LC-HRMS).

FDA urges ranitidine drug manufacturers to test their product for NDMA levels and to send samples to the agency to be tested.

Recalls of Ranitidine

On September 24, FDA announced the voluntary recall by Sandoz of 14 lots of prescription ranitidine capsules following detection of NDMA.

On September 26, FDA announced the voluntary recall by Apotex of Ranitidine Tablets 75mg and 150mg in all pack sizes and formats through to the retail level.

On September 30, CVS pulled Zantac and its own generic form from the shelves.

How Avomeen Can Help

Avomeen’s industry-leading expert analytical chemists have extensive experience with impurities in drug products. If you are interested in NDMA impurity testing of ranitidine or other drug impurity testing, let’s talk.

Additional Resources

FDA now requires manufacturers to test each lot of ranitidine medication prior to release to patients and consumers. Check out our blog for more information.

 

Our featured blogger is Christine Butler, Avomeen’s Director of Business Development for the Southeast region. Christine has been involved in the OTC drug industry for nearly 15 years, from working in analytical method development and validations to serving in project management and business development roles for contract manufacturing organizations supporting the OTC Consumer Healthcare industry.