FDA Warns India-Based Solvent Recovery Company Over Valsartan Recalls

Published on August 15, 2019 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) is targeting yet another overseas company in connection with the ongoing valsartan recalls.

Lantech Pharmaceuticals Warning Letter

India-based Lantech Pharaceuticals apparently acted as a solvent recovery facility for other companies that manufacture active pharmaceutical ingredient (API) used in valsartan, a generic version of Diovan. The FDA placed Lantech on Import Alert in June, after an inspection of the firm’s processing facility in Ranastalam uncovered conditions that could have contributed to the production of contaminated drugs.

“Given that your firm does not maintain logbooks or documentation demonstrating product use or cleaning associated with the use of these tanks, there is a potential for all products manufactured at your facility to contain nitrosamines through mix-ups or cross contamination,” the agency said in a Warning Letter dated August 8th.

About the Valsartan Recalls

The generic valsartan recalls began last summer, when the first of three potentially cancer-causing nitrosamines were detected in active pharmaceutical ingredients sourced from Chinese and Indian manufacturers. Eventually, the impurities turned up in valsartan, irbesartan, and losartan products manufactured and distributed by multiple generic drug makers in nearly two dozen countries.

According to the FDA, the contaminated products were in circulation for at least four years. Patients are advised to check the agency’s regularly updated lists of recalled  valsartan, losartan and irbesartan products to determine if their medication is included. If so, they should contact their doctor or pharmacist for replacement. However, they should not stop taking the drug until they have obtained a replacement, as stopping treatment could lead to serious adverse health events.

Dozens of valsartan lawsuits have been filed in the wake of the recalls, including personal injury claims that blame the tainted drugs for causing cancer. Legal experts believe the litigation involving contaminated valsartan, losartan, and irbesartan medications could eventually grow to include thousands of similar claims.

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