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FDA Issues Warning to Drug Manufacturer Mylan

December 06, 2019

USA- The Food and Drug Administration (FDA) issued a warning to an Indian manufacturing plant that manufactures the blood pressure medication, Valsartan, after contamination findings, according to*

The Indian plant, called Mylan, issued a recall last spring after discovering certain batches of the drug were contaminated with a carcinogenic substance called N-Nitrosodiethylamine, often shortened to NDEA.  NDEA is a probable human carcinogen, meaning it can cause cancer.  While found in water and food, the FDA has stated previously that the presence of NDEA in drugs is unacceptable.  

The recall then led to an investigation carried out by the FDA. The Mylan recall was one of many recalls made concerning the sartan family of drugs. Many of the drugs were found to contain impurities. According to the investigation into the Mylan facility, the manufacturer does not have proper procedures in place to identify contaminants found in the raw materials used to make the drugs.

The letter sent to Mylan indicates that the manufacturer did not correctly document which tanks certain solvents were contained in, leading to potential cross-contamination. The facility also failed to use proper methods to clean and sterilize its utensils and equipment. The inspectors found remnants of Valsartan on chutes that were meant to be sterile.

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Category: Product Liability

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All information provided by our blogs is general in nature and should not be relied upon as legal advice. Consult a Montlick attorney for details about your unique situation.