Losartan Potassium Recall Issued Over NDEA Impurities

Federal regulators have issued another generic drug recall due to manufacturing impurities that could increase the risk of cancer, indicating that losartan potassium tablets distributed by Torrent Pharmaceuticals may be contaminated with N-nitrosodiethylamine (NDEA). 

The losartan potassium recall was announced on December 20, as the latest in a string of recalls involving various hypertension drugs that have been linked to problems with NDEA, and other similar contaminants that may be a byproduct of the generic manufacturing processes.

The recalled drug is a generic version of Cozaar, and belongs to a class of medications known as angiotensin II receptor antagonists. The active ingredient, losartan, was manufactured by Hetero Labs Limited, which has been linked to other drug contamination recalls in recent months.

Losartan potassium tablets distributed by Torrent Pharmaceuticals are impacted by the recall, including tablets sold in 100mg, 30-count bodies under NDC 13668-115-30 with a lot number of BO31C016; and 100mg, 1,000-count bottles sold under NDC 13668-115-10 with a lot number of 4DK3C005. All of the affected pills have an expiration date of 04.2019.

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 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.

A few weeks ago, 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 Medimfo.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.