Torrent Pharmaceuticals is recalling half-a-dozen lots of losartan HCTZ, after testing detected trace amounts of N-nitrosodiethylamine (NDEA) in the active ingredient used to manufacture the drugs.
This marks the second time this month that Torrent has expanded its losartan recall.
The initial action was announced on December 20th and included eight lots of losartan tablets. Two additional lots of losartan were added to the recall on January 3rd.
Losartan is used to treat:
Patients with recalled losartan or losartan HCTZ should contact their doctor or pharmacist to arrange for a replacement. However, they should not stop taking their losartan medication in the interim, as doing so could result in serious adverse health consequences.
To date, Torrent has not received any adverse event reports in relation to its losartan recall.
Consumers wishing to report adverse events, or who have medical questions related to this recall, can contact Torrent Pharmaceuticals by calling 1-800-912-9561, or email the company at: Medinfo.Torrent@apcerls.com
NDEA is one of two potentially cancer-causing chemicals that have been detected in active ingredient used to manufacture losartan and other generic angiotensin II receptor blockers (ARBs).
N-nitrosodimethylamine (NDMA) was first detected in generic valsartan last June.
As a result, generic manufacturers in the United States and 22 other countries have been forced to announce recalls for the following ARBs:
NDEA and NDMA are both considered probable human carcinogens. In fact, animal testing suggests exposure to these compounds may cause kidney cancer, liver cancer, colorectal cancer, respiratory, stomach cancer, and bladder cancer.
The contaminated active pharmaceutical ingredient behind Torrent’s losartan recall was supplied by India-based Hetero Labs. However, most of the recalled ARBs contained active ingredient manufactured by Zhejiang Huahai Pharmaceuticals of China.
These tainted drugs may have been in circulation for over four years, as NDEA and NDMA were likely byproducts of a production method the two companies instituted in 2014.
The FDA has posted updated lists of valsartan products under recall, drugs included in the losartan recall, and irbesartan products under recall at its website.
Since the ARB recalls began last year, the FDA has banned Zhejiang Huahai Pharmaceuticals from importing active pharmaceutical ingredients and finished drug products to the United States.
The agency has also established acceptable intake levels for nitrosamine impurities in ARBs, updated its testing methods, and begun testing all of these drugs for the presence of NDEA and NDMA.
So far, the vast majority of ARB recalls involve generic valsartan products.
Not surprisingly, a growing number of valsartan lawsuits have been filed on behalf of patients who claim the tainted drugs caused their cancer. Next week, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear Oral Arguments on proposal to centralize all such federal claims in a single jurisdiction for coordinated pretrial-proceedings.