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FDA Releases an Additional LC-MS Method for Testing NDMA in Ranitidine (Zantac)

New LC-MS/MS method provides an alternative to the current LC-HRMS method

Rachel Muenz

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On Oct. 23, the US Food & Drug Administration released a second liquid chromatography-mass spectrometry (LC-MS) method for detecting and quantifying NDMA in ranitidine drug products and substances. The nitrosamine impurity in such drugs was first brought to the attention of the FDA in September, as it is known to be a probable human carcinogen above certain levels. The new method, a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, was developed and validated following ICH Q2 (R1), the FDA said.

Though the FDA has not asked people to stop taking ranitidine drugs, commonly used to treat the effects of acid indigestion and known best by the brand name Zantac, it also announced several more voluntary recalls of such drugs on Oct. 23 and 28.

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Related Article: NDMA Testing Methods

Dr. Reddy’s Laboratories Ltd recalled all prescription and over the counter (OTC) ranitidine capsules and tablets it manufactures while Sanofi recalled all its OTC ranitidine, the FDA announced on Oct. 23. On Oct. 28, the FDA announced that Perrigo Company plc, Novitium Pharma LLC, and Lannett Company, Inc. had voluntarily recalled several more ranitidine products.

The FDA is continuing to monitor the situation and evaluate the safety of ranitidine products. It has stressed that anyone concerned about taking ranitidine should consult their health care professional about alternative treatments.

In Canada, regulator Health Canada has requested companies stop distribution of ranitidine and several products have been recalled. Most recently, Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc., and Vita Health Inc. recalled all OTC and prescription ranitidine products from the Canadian market, while on Oct. 30, Ranbaxy Pharmaceuticals Canada Inc. recalled all of its prescription ranitidine products as a precaution.