Valsartan/HCT from Teva B.V.
Recall
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Medicines
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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 recall | 1 |
| BASG reference number | INS-640.001-2690 |
Further inquiry note
Page last modified:
12/07/2022