Valsartan and Valsartan/HCT from Teva B.V.
Recall
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Medicines
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05/07/2018
The marketing authorization holder has informed its customers in a letter dated December 31, 2009, that a production-related impurity has arisen at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine (NDMA), which is classified as a potential carcinogen.
Therefore, a recall of "Valsartan G.L. Film-Coated Tablets" and "Valsax Film-Coated Tablets" in the strengths 80 mg and 160 mg, "Valsartan-HCT G.L. Film-Coated Tablets" and "CO-Valsax Film-Coated Tablets" in the strengths 160 mg/12.5 mg and 160 mg/25 mg is being carried out exclusively for the above mentioned batches.
| Name of the medicinal product | 1. Valsartan G.L. 80 mg –Filmtabletten 2. Valsartan G.L. 160 mg – Filmtabletten 3. Valsax 80 mg – Filmtabletten 4. Valsax 160 mg – Filmtabletten 5. Valsartan - HCT G.L. 160 mg/12,5 mg – Filmtabletten 6. Valsartan-HCT G.L. 160 mg/25 mg – Filmtabletten 7. CO-Valsax 160 mg/12,5 mg – Filmtabletten 8. CO-Valsax 160 mg/25 mg – Filmtabletten |
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| Marketing authorisation number(s) | 1. 1-30639 2. 1-30645 3. 1-30649 4. 1-30650 5. 1-30659 6. 1-30660 7. 1-30664 8. 1-30665 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | 1. 6E152A, 7M161A 2. 6C185A, 6C185B, 7F205A 3. 6E152A, 6E152B, 7M161A 4. 6C185A, 6C185B, 6K242A, 6K242B, 7F205A, 7F205B 5. 6D195A, 6D195B 6. 5L169A, 5L169B, 7M162A 7. 5L170A, 5L170B, 6D195A, 6D195B, 7L283A 8. 5L169A, 5L169B, 5L169C, 5L169D, 7M162A |
| BASG reference number | INS-640.001-2582 |
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Page last modified:
12/07/2022