Valsartan and Valsartan/HCT from 1A Pharma GmbH
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 |
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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 recall | 1 |
BASG reference number | INS-640.001-2576 |