Valsartan NDMA Cancer-Causing Impurity Results in Recall Expansion

Following a number of different generic valsartan recalls issued in recent months, drug makers indicate that even more lots of both valsartan tablets and combination drugs may include an impurity known as N-nitrosodimethylamine (NDMA), which has been linked to a risk of liver cancer, kidney cancer and other types of cancer. 

The FDA announced late last week that Torrent Pharmaceutical is expanding it’s recall due to valsartan NDMA concerns, indicating that combination drugs that include amlopidine and amlopidine plus hydrochlorothiazide (HCTZ) may also be contaminated.

Torrent Pharmaceuticals initially announced a valsartan/amiodipine/HCTZ tablet recall on August 17, joining a number of different generic drug makers who have indicated in recent weeks that drugs distributed in recent years may be contaminated with NDMA at levels that could increase the risk of cancer.

The first valsartan recalls were announced in Europe on July 5, after batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA. That initial recall affected about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada. The same manufacturer made the recalled Torrent Pharmaceutical pills.

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers.

The agency determined that a number of manufacturers have been distributing the contaminated pills for years. Like the EMA, the FDA also noted NDMA has been linked to cancer risks in animal studies and that the U.S. Environmental Protection Agency (EPA) determined that consuming up to 96 nanograms of NDMA per day is considered reasonably safe for human ingestion.

The latest recall affects all lots of valsartan, Amlodipine and Valsartan Tablets, and  valsartan/amlodipine/HCTZ tablets with expiration dates ranging from Aug 2018 to Jan 2020. A complete list of the affected medications is available on the FDA recall notice, linked above.

Consumers with questions regarding this recall can call Torrent Pharmaceuticals Limited at 1-800-912-9561.

The FDA requests that any consumers or healthcare providers who experience an adverse event linked to the recalled products file a report with the FDA’s MedWatch Adverse Event Reporting program.

A number of consumers who have been diagnosed with liver cancer, kidney cancer, lung cancer or suffered an acute liver injury in recent years are now reviewing whether they may be eligible for compensation through a valsartan lawsuit against the manufacturers of the generic drug, with lawyers providing free consultations and case evaluations for individuals nationwide.