CO-Valsax and Valsartan-HCT from G.L. Pharma GmbH
Recall
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Medicines
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14/08/2018
The marketing authorization holder informed its supplied customers in a letter dated July 5, 2018, that a production-related impurity occurred at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine (NDMA), which is classified as a potential carcinogen. Therefore, the affected batches were recalled.Since further batches of active ingredient were identified at the active ingredient manufacturer, the marketing authorization holder informed its supplied customers in a letter dated August 4, 2018, that the recall will be supplemented by "CO-Valsax 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan-HCT G.L. 80 mg/12.5 mg Film-Coated Tablets" with the above-mentioned batches.
| Name of the medicinal product | 1. CO-Valsax 80 mg/12,5 mg-Filmtabletten 2. Valsartan-HCT G.L. 80 mg/12,5 mg-Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-30663 2. 1-30658 |
| Marketing authorisation holder | G.L. Pharma GmbH |
| Batch number(s) | 1. 5G258E, 5G258F 2. 5G258C, 5G258D |
| Classification of the recall | 1 |
| BASG reference number | INS-640.001-2582 |
Further inquiry note
Page last modified:
12/07/2022