The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is undertaking a pharmacy level recall of all affected batches of valsartan containing medicines made by Mylan (Nasdaq: MYL) and Teva Pharmaceutical Industries (NYSE: TEVA) as a precautionary measure.
This follows an earlier pharmacy level recall in July, when MHRA recalled affected batches of valsartan containing medicines from Dexcel and Actavis (now Accord), also to pharmacy level.
That recall occurred across Europe, following information that an impurity, N-nitrosodimethylamine (NDMA) was identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China.
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