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On November 20, Mylan Pharmaceuticals issued a voluntary nationwide recall of select lots of high blood pressure medicines, due to the presence of N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.
NDEA is classified by the International Agency for Research on Cancer as a probable carcinogen.
Yesterday, Mylan – which manufactures the API in Hyderabad, India – announced the contamination has prompted the firm to expand its nationwide recall, to now include all lots of valsartan tablets, amlodipine and valsartan tablets, and valsartan and hydrochlorothiazide tablets, within expiry.
The additional 104 lots were distributed in the US between March 2017 and November 2018, and are listed here.
Mylan Laboratories Limited also manufactures valsartan for Teva Pharmaceuticals USA. Last month, the detection of NDEA in the latter’s valsartan-containing medicines prompted Teva to issue a voluntary recall.
In Europe, authorities have similarly detected NDEA in some batches of Mylan’s valsartan API, and have suspended its use in medicines for the region.