Teva Pharmaceuticals USA has issued a voluntary nationwide recall of all amlodipine/valsartan combination tablets and amlodipine/vastartan/hydrochlorothiazide combination tablets within expiry. Both combination products are used for the treatment of high blood pressure.
According to Teva, the presence of N-nitroso-diethylamine (NDEA) – classified by the International Agency for Research on Cancer as a probable carcinogen – in the products’ valsartan active pharmaceutical ingredient (API), prompted the recall.
The contaminated API was manufactured by Mylan in Hyderabad, India. This same contamination was also detected by EU authorities, which last week, made the decision to suspend the use of Mylan’s Hyderabad-made valsartan in Europe.
Mylan is the latest API manufacturer to be affected by NDEA, or related compound N-nitrosodimethylamine (NDMA), contaminations, after impurities were found in Chinese firm Zhejiang Huahai Pharmaceuticals’ valsartan, and Indian firms Hetero Labs and Aurobindo Pharma Limited’s losartan and irbesartan, respectively.
Manufacturing concerns
In a separate GMP issue, earlier this month the US Food and Drug Administration (FDA) sent Mylan a warning letter relating to the firm’s manufacturing facility in Morgantown, West Virginia.
The letter references a Form 483 with thirteen observations issued by US regulators in April this year. According to the Mylan, the company has implemented “comprehensive restructuring and remediation” at its Morgantown facility.
