Valsartan/HCT from Teva B.V.

Recall | Medicines | 23/11/2018

The marketing authorization holder informed its supplied customers in a letter dated November 23, 2018, that the active ingredient manufacturer Mylan Laboratory Limited in India has detected the production-related impurity N-nitrosodiethylamine (NDEA) in the active ingredient valsartan. Therefore, the batches of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and of "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" listed above are being recalled.

Name of the medicinal product 1) Valsartan/HCT ratiopharm 80 mg/12,5 mg Filmtabletten
2) Valsartan/HCT ratiopharm 160 mg/25 mg Filmtabletten
Marketing authorisation number(s) 1) 1-27777
2) 1-27778
Marketing authorisation holder Teva B.V.
Batch number(s) 1) 0001586, 0002626, 0003214, 0004745, 0006204, 6P601162, 6P606334
2) 0000355, 0000356, 0001612, 0003613, 6P606289, 6P606320
Classification of the recall1
BASG reference number INS-640.001-2690

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