Common Blood Pressure Medication Recalled After Cancer-Causing Chemical Found: FDA

A pharmaceutical company said some of its blood pressure medication is being recalled after the presence of a cancer-causing agent was discovered in two lots, according to the U.S. Food and Drug Administration (FDA) on Dec. 20.

Torrent Pharmaceuticals Limited said it is voluntarily recalling two lots of Losartan potassium tablets, used to treat high blood pressure (hypertension), after traces of N-nitrosodiethylamine (NDEA) were discovered. NDEA is a known cause of cancer and occurs naturally in “certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen,” the FDA stated. The active pharmaceutical ingredient, which contains the NDEA, was manufactured by Hetero Labs Limited.

No “events related to this recall” have been reported by Torrent Pharmaceuticals, the FDA said.

The FDA recommends users of the Losartan potassium tablets to continue taking them because “the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.”

Patients are advised to talk to their doctor or pharmacist who can talk to them about alternative treatment methods.

Regarding the recall, the product can be identified by looking at the product name, manufacturer details, and batch or lot number on the bottle.

A list of recalled lots can be viewed on the FDA’s website.

The FDA recommends users of the Losartan potassium tablets to continue taking them because “the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.” FDA

Meanwhile, “Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers,” the FDA’s news release said.

Torrent is notifying its distributors and customers via phone and in writing to immediately discontinue distribution of the recalled lots, it added.

Consumers who have questions about the recall can contact Torrent Pharmaceuticals at 1-800-912-9561.

Torrent Pharmaceuticals is an India-based firm and operates in more than 50 countries. Hetero Labs is also an Indian company, shipping drugs to more than 125 countries.

Warning to Chinese Company

Earlier this month, the FDA warned a Chinese drug manufacturer, Zhejiang Huahai Pharmaceutical Co. Ltd., for “several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control, and cross-contamination from one manufacturing process line to another.”

Zhejiang Huahai Pharmaceutical was also placed “on import alert” by the FDA earlier this year due to impurities in valsartan, another blood pressure medication.

Chinese workers preparing to destroy fake medicines seized in Beijing, on March 14, 2013. The U.S. Food and Drug Administration announced on July 13, 2018, the recall of the heart medicine valsartan, made by Chinese firm Zhejiang Huahai, which was found to be contaminated by a carcinogen. STR/AFP/Getty Images

The valsartan recall was first initiated in July after N-Nitrosodimethylamine (NDMA) was discovered in the drug. NDMA is also a known carcinogen. Other investigations triggered recalls of other valsartan-containing drugs along with irbesartan- and losartan-containing products, the FDA said.

“The FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities,” said the FDA.