Drugs

Laboratory analysis of valsartan products

FDA continues to investigate the presence of impurities in valsartan products and other angiotensin II receptor blockers (ARBs) used to treat high blood pressure and heart failure. FDA recently identified the impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in certain valsartan products. FDA is posting its test results showing NDMA levels in recalled valsartan products. FDA will also post test results and an assessment of the cancer risk from NDEA when they are available.

The table below shows the NDMA test results for the recalled valsartan products. The analyses reflect average levels of NDMA present in a single tablet based on the strength of the tested drug product within the lots tested, which are identified in the table. Some of products listed below may have been repackaged by other companies as noted in FDA’s list of valsartan products under recall. For reference, consuming up to 0.096 micrograms of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure.

FDA previously estimated that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people. That estimate was based on the highest daily dose, however many people may have taken lower doses, and therefore their risks would theoretically be less. FDA expects the actual cancer risk to most consumers to be lower than our estimate.

Company Product (tablets) Lots Tested NDMA level (micrograms -mcg/tablet) 
Hetero Labs Ltd Valsartan 320mg VLS18049, VLS18051, VLS18050 0.3-0.4
Prinston Pharmaceutical Valsartan 320mg/HCTZ 25mg 611B18025, 611B18026, 611B18027 13-20
Prinston Pharmaceutical Valsartan 320mg 344B18027, 344B18028, 344B18029 15-16
Teva Pharmaceuticals Valsartan 320mg 1240425A, 1247282M, 1263943A 8-17
Teva Pharmaceuticals Valsartan 320mg/HCTZ 25mg 1217576M, 1217577M, 1217578M 7-10
Torrent Pharmaceuticals Amlodipine 10mg/Valsartan 320 mg/HCTZ 25mg BBX2E001, BBX2E002, BBX2E003 10-12
Torrent Pharmaceuticals Amlodipine 10mg/Valsartan 320 mg BV77E001, BV77E002, BV77E003 5-9
Torrent Pharmaceuticals Valsartan 320mg BV48D001, BV48D002 0.5-0.6
For the valsartan products that were not recalled, based on the lots FDA tested, all of the NDMA test results were below the limit of quantification of our testing method. This means the impurity either was not present or the levels were so low that our testing method did not reliably measure it.

Page Last Updated: 10/10/2018
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