Losartan Recall Expanded Over NDEA Impurities

Amid continuing concerns about a cancer risk associated with certain generic blood pressure drugs that may contain a carcinogenic impurity, federal regulators indicate that a recent losartan recall has been expanded by a factor of six, as more lots appear to pose a risk for consumers. 

The FDA announced the Torrent Pharmaceuticals losartan potassium tablet recall expansion on January 3, with the company indicating that another 10 lots of the generic hypertension drug may contain the chemical N-nitrosodiethylamine (NDEA), which is a byproduct of the generic drug’s manufacturing process, resulting in levels above those considered safe for humans.

Torrent announced the initial recall on December 20, after detecting NDEA in two lots of the active ingredient manufactured by Hetero Labs Limited. The expansion increases the recall to 12 lots of the drug, which is a generic version of the blood pressure medication Cozaar.

The action impacts Losartan Potassium Tablets, USP, manufactured by Torrent Pharmaceuticals LTD., which were sold in 100mg, 50mg and 25mg strengths. They were sold in 30, 90, and 1,000-count bottles with expiration dates ranging from 04,2019 to 05/2021. The complete list of lot numbers, batch numbers and NDC codes are available in the expanded recall notice.

The tablets were distributed nationwide to wholesale distributors, repackagers and retail customers.

Hypertension Drug Cancer Concerns

NDEA occurs naturally in certain foods and drinking water, but can be created as a byproduct of industrial processes, which is what the FDA believes occurred in this instance and with recent valsartan recalls linked to the presence of a similar impurity, N-nitrosodimethylamine (NDMA). Both are considered probably cancer-causing agents by the International Agency for Research on Cancer (IARC).

The first valsartan problems surfaced in July, when European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for NDMA.

The FDA followed with its own recall announcement the following week, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers. Since that time, the recall has been expanded several times, impacting a variety of manufacturers of the generic drug.

In late October 2018, the first non-valsartan drugs were recalled, after problems with 22 batches of irbesartan were announced due to cancer-causing impurity. That was followed by the first losartan recall issued on November 11.

The FDA is continuing to test other valsartan drugs, as well as other similar hypertension drugs, like losartan. The FDA is asking patients who use the drugs to regularly check its updated list of recalled valsartan drugs, recalled irbesartan drugs, and its list of valsartan drugs that have not been recalled.

As more individuals discover that they may have received contaminated pills, a growing number of valsartan recall lawsuits are being filed, including claims that individuals may have avoided a cancer diagnosis if NDMA has not been in the generic hypertension drugs.

Consumers with questions about the latest recall, and those who have suffered an adverse event, can contact Torrent Pharmaceuticals Limited by calling 1-800-912-9561 or by sending an email to Medinfo.Torrent@apcerts.com.

The FDA also urges doctors and patients who experience adverse events while taking these drugs to submit a report to the FDA MedWatch adverse event reporting system.