Valsartan, Valsax, Valsartan-HCT and CO-Valsax from G.L. Pharma GmbH
Recall
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Medicines
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05/07/2018
The marketing authorization holder informed its supplied customers in a letter dated December 31, 2009, that a production-related impurity occurred during a synthesis step at the active ingredient manufacturer's. The impurity is N-nitrosodimethylamine (NDMA). 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 strengths of 80mg and 160 mg, "Valsartan-HCT G.L. Film-Coated Tablets" and "CO-Valsax Film-Coated Tablets" in the strengths 160mg/12.5 mg and 160mg/25 mg exclusively for 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-640.001-2 582 |
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Page last modified:
12/07/2022