Valsartan and Valsartan/HCT from Actavis Group PTC ehf
Recall
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Medicines
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05/07/2018
In a letter dated July 5, 2018, the marketing authorization holder informed its customers that the active ingredient manufacturer had detected the production-related impurity N-nitrosodimethylamine (NDMA) in the active ingredient valsartan. Therefore, the above mentioned batches of "Valsartan Actavis Film-Coated Tablets" in the strengths 40mg, 80mg, 160mg, of "Valsartan/HCT Actavis Film-Coated Tablets" the strengths 80 mg/12.5 mg, 160mg/12.5mg and 160 mg/25 mg are recalled.
Name of the medicinal product | 1. Valsartan Actavis 40 mg Filmtabletten 2. Valsartan Actavis 80 mg Filmtabletten 3. Valsartan Actavis 160 mg Filmtabletten 4. Valsartan/HCT Actavis 80 mg/12,5 mg Filmtabletten 5. Valsartan/HCT Actavis 160 mg/12,5 mg Filmtabletten 6. Valsartan/HCT Actavis 160 mg/25 mg Filmtabletten |
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Marketing authorisation number(s) | 1. 1-28263 2. 1-28264 3. 1-28265 4. 1-28540 5. 1-28541 6. 1-28542 |
Marketing authorisation holder | Actavis Group PTC ehf |
Batch number(s) | 1. 448815, 366116, 229317, 365317 2. 306115, 484015, 18816, 289816, 401916, 459016, 120617, 164717, 488317, 151118 3. 388215, 483915, 15816, 180716, 290016, 412316, 439216, 82517, 119817, 210017, 288417, 301717, 102618 4. 132616, 290416, 64417, 210117, 157118 5. 179716, 291016, 440516, 53317, 170217, 419417, 104518 6. 189516, 291116, 52417, 218517, 259617 |
Classification of the recall | 1 |
BASG reference number | INS-640.001-2583 |
Further inquiry note
Page last modified:
12/07/2022