Valsartan and Valsartan/HCT from Actavis Group PTC ehf

Recall | Medicines | 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
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 recall1
BASG reference number INS-640.001-2583
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