Valsartan and Valsartan/HCT from 1A Pharma GmbH

Recall | Medicines | 06/07/2018

The marketing authorization holder informed its supplied customers in a letter dated 06.07.2018 that a production-related contamination of the active ingredient was detected. The substance in question is N-nitrosodimethylamine (NDMA). Therefore, a precautionary recall of all batches of "Valsartan 1A Pharma Film-Coated Tablets" of the strengths 80mg and 160mg as well as "Valsartan/HCT 1A Pharma Film-Coated Tablets" in the strengths 80 mg/12.5 mg, 160 mg/12.5 mg and 160mg/25 mg on the market is being carried out.

Name of the medicinal product 1. Valsartan 1A Pharma 80 mg –Filmtabletten
2. Valsartan 1A Pharma 160 mg – Filmtabletten
3. Valsartan/HCT 1A Pharma 80 mg/12,5 mg – Filmtabletten
4. Valsartan/HCT 1A Pharma 160mg/12,5 mg – Filmtabletten
5. Valsartan/HCT 1A Pharma 160 mg/25 mg - Filmtabletten
Marketing authorisation number(s) 1. 1-29516
2. 1-29517
3. 1-29546
4. 1-29547
5. 1-29548
Marketing authorisation holder 1A Pharma GmbH
Batch number(s) Alle in der Laufzeit befindlichen Chargen, nämlich:

1.GC2269, GL0015, GP1758, GX0065, HB7711, HE3808, HK6308, HV9446, HW7314
2. FY4284, GD9160, GM1341, GU1974, HA7394, HF1553, HW3573
3. FW0324, GF4541AA, GN9218, HA3204, HV6902
4. FT3228, FZ0848, GK6306, GT4735, GT4736, HJ6146
5. FR6591, FW6899, GK6439, GU2629, GX0337, HW8597
Classification of the recall1
BASG reference number INS-640.001-2576

Further inquiry note