Torrent Pharmaceuticals Draws FDA Warning Letter for Tainted Losartan

Published on October 17, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) is taking Torrent Pharmaceuticals to task over substandard conditions at a plant in Taluka-Kadi, Gujarat, India.

The facility manufactured contaminated losartan tablets involved in five recalls over the last year.

FDA Inspection Found “Significant Violations” at Torrent Pharmaceuticals Plant

According to an FDA Warning Letter sent to Torrent Pharmaceuticals on October 8^th, an inspection of the Indian plant conducted from April 8 to 16, 2019 uncovered “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

Those violations included:

• The failure to follow written procedures for production and process control designed to ensure the identity, strength, quality, and purity of drug products manufactured at the facility.
• The failure to thoroughly investigate when a drug batch or any of its components failed to meet any of its specifications, whether or not the batch has already been distributed.

The FDA gave Torrent Pharmaceuticals 15 days to respond to the letter, specifying what has been done since the inspection to correct the violations and prevent their reoccurrence. The agency also threatened to withhold new drug approvals pending confirmation that the violations had been corrected.

Losartan, Other ARBs Tainted with Cancer-Causing Nitrosamines

Losartan is one of several angiotensin II receptor blockers (ARBs) recalled by various generic drug makers since last summer following the discovery of potentially cancer-causing nitrosamines in active ingredients supplied by companies in China and India.

The recalls, which also include generic valsartan and irbesartan products, have ensnared dozens of companies in the United States and 22 other countries. Torrent Pharmaceuticals announced its fifth losartan recall just last month.

Losartan, valsartan, and irbesartan-containing medications are indicated to treat high blood pressure and heart failure. The ongoing recalls don’t include all generic ARBs currently on the market. To determine if a specific medication has been recalled, consumers should refer the FDA website or check with their doctor or pharmacy.

Consumers prescribed a recalled valsartan, irbesartan, or losartan product should contact their healthcare provider for a replacement. However, it’s important they continue taking their ARB while waiting for a replacement, as stopping treatment entirely could result in dangerous, and even deadly, heart or blood pressure events.

Valsartan Recall Lawsuits

Valsartan-based drugs were the first ARBs involved in the recalls.

There are more the 140 valsartan lawsuits pending in a multidistrict litigation now underway in the U.S. District Court, District of New Jersey. The cases include personal injury claims filed on behalf of cancer victims, as well as class action lawsuits that seek economic damages and medical monitoring for consumers who purchased recalled valsartan products.

Recently, plaintiffs pursuing irbesartan and losartan lawsuits requested that the federal litigation be expanded to include those claims as well.