Aurobindo Pharmaceuticals, one of multiple generic drug makers to announce valsartan recalls over the past year, has received a Warning Letter from the U.S. Food & Drug Administration (FDA) for repeated violations at three plants in India.
The FDA apparently inspected one of the Aurobindo plants in February, after tests detected impurities in several batches of active pharmaceutical ingredients manufactured at that site. Although the agency did not specify the products involved, the impurities were likely related to the company’s recent valsartan recalls.
According to the June 20th Warning letter, Aurobindo didn’t adequately investigate either the contamination concerns or equipment maintenance issues that could impact the quality of drugs produced by that facility. Similar deficiencies were uncovered at the two other plants.
“These facilities are also considered to be in an unacceptable state of compliance with regards to CGMP,” the FDA states. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate.”
Aurobindo has 15 working days to address the problems detailed by the FDA Warning Letter. The agency has the authority to withhold new drug approvals while the three facilities remain out of compliance. Aurobindo’s products could also be prohibited from entering the United States should the company fail to comply with the letter’s directives.
Valsartan is the generic name for Diovan, an angiotensin II receptor blocker (ARB) indicated to treat high blood pressure and heart failure.
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 tainted drugs were in circulation for at least four years. Patients who take generic ARBs should consult 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, to avoid potentially life-threatening heart or blood pressure complications, all patients should continue to take their recalled ARBs until a replacement drug is actually in their possession.
Legal experts believe thousands of plaintiffs will eventually file legal claims related to the ARB recalls.
In fact, 60 valsartan lawsuits were already undergoing centralized pretrial proceedings in New Jersey federal court as of June 15th. More than half of those cases blame tainted medications for causing cancer, while the remaining seek economic damages and medical monitoring for consumers who purchased recalled valsartan.
Claims related to the losartan and irbesartan recalls are also mounting, but have yet to be centralized in a single jurisdiction.