Mylan Hit with FDA Warning Following Valsartan Recall

Published on November 22, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) recently issued a Warning Letter to Mylan Pharmaceuticals, after an inspection of a manufacturing facility in India uncovered “significant deviations” from good manufacturing practice that likely contributed to the company’s massive valsartan recall.

Mylan recalled all of its valsartan products last December.

Mylan Plant in India Made Recalled Valsartan

The Mylan plant in Andhra Pradesh apparently manufactures active ingredient for valsartan, a medication used to treat heart failure and high blood pressure that’s been at the center of numerous recalls for more than a year.

According to the November 5^th letter, FDA inspectors were onsite in India from May 27 to June 5, 2019. Over the course of their visit, they cited the facility for failing to:

• Have adequate written procedures for the receipt, identification, testing and handling of raw materials.
• Clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the ingredients beyond the official or other established specifications.

“Your procedures for receiving, identifying, testing, and handling raw materials were inadequate to ensure suitability of materials used in manufacturing, including preventing contamination and cross-contamination with nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA),” the FDA wrote. “Your film had not anticipated the presence of NDMA or NDEA impurities based on your assessment of the API manufacturing process.”

The agency gave Mylan 15 business days to correct the violations and recommended it retain a consultant to help it do so.

About the Valsartan Recall

Generic drug makers around the world began recalling valsartan, irbesartan, and losartan-containing medications in July 2018, after NDMA – a probable human carcinogen – was detected in active pharmaceutical ingredient produced by several suppliers in India and China.

Since then, tests have found two other potentially cancer-causing nitrosamines in active ingredient used to manufacture generic “sartan” medications.

The FDA believes the nitrosamine contamination resulted from a change in production methods instituted by overseas manufacturers roughly four years before the first valsartan recall. Thus, it’s likely that contaminated heart and blood pressure drugs had been on the market for at least four years.

More than a year later, the sartan recalls continue. Patients who using generic versions of valsartan, losartan, and irbesartan should check the FDA’s regularly updated lists to determine if their medication has been recalled.

Consumers who have a recalled drug should contact their doctor or pharmacist for a replacement. However, they should continue using the medication until the replacement drug is in hand, as stopping treatment entirely could result in potentially life-threatening heart and blood pressure events.