Recall of drugs containing the active ingredient valsartan from the Chinese manufacturer Zhejiang Huahai Pharmaceutical
A batch-related recall of medicines containing valsartan, the active ingredient of which was produced by the Chinese manufacturer Zhejiang Huahai Pharmaceutical, is currently taking place in the European Union. The affected drugs are used to treat hypertension.
The reason for the recall is a possible production-related contamination of the active ingredient with N-nitrosodimethylamine. This substance is classified by the WHO's International Agency for Research on Cancer and the EU as a probable human carcinogen. So far, no information is available on whether and in what concentrations the impurity is contained in these medicines. The recall of all affected batches is therefore being carried out throughout Europe as a precautionary measure until the facts of the matter have been clarified.
An initial scientific assessment of the hazard potential has already been carried out at European level and an acute hazard can be ruled out at the present time. However, since such contamination cannot be tolerated on the basis of the precautionary principle, a recall of all potentially affected medicines will be carried out. Further investigations are underway throughout Europe and are being coordinated by the European Medicines Agency (EMA) and agreed jointly with the member states. The aim of the procedure is to take harmonized measures throughout Europe to protect patients.
Patients taking medicines containing valsartan should not discontinue the medicines under any circumstances without consulting their doctor, as the health risk of discontinuation is many times higher than the potential risk from contamination. There is no acute patient risk.
Situation in Austria
In Austria, the following marketed drugs are affected: (as of Aug. 14, 2018).
Information on the affected lot numbers can be found in the BASG safety letters regarding the recalls.
Name of the medicinal product | Marketing Authorization Number | Batch number | Marketing Authorization Holder |
Valsartan-HCT +pharma 160 mg/12.5 mg Film-Coated Tablets | 1-31510 | All batches in the runtime | +pharma arzneimittel gmbh |
Valsartan-HCT +pharma 80 mg/12.5 mg film-coated tablets | 1-31509 | All batches in the maturity period | +pharma arzneimittel gmbh |
Valsartan-HCT +pharma 160 mg/25 mg film-coated tablets | 1-31511 | All batches in the maturity period | +pharma arzneimittel gmbh |
Valsartan +pharma 320 mg - film-coated tablets | 1-30679 | All batches in the maturity period | +pharma arzneimittel gmbh |
Valsartan +pharma 80 mg film-coated tablets | 1-30677 | All batches in the maturity period | +pharma arzneimittel gmbh |
Valsartan +pharma 160 mg film-coated tablets | 1-30678 | All batches in the maturity period | +pharma arzneimittel gmbh |
Valsartan 1A Pharma 80 mg - film-coated tablets | 1-29516 | GC2269, GL0015, GP1758, GX0065, HB7711, HE3808, HK6308, HV9446, HW7314 | 1A Pharma Ltd. |
Valsartan 1A Pharma 160 mg - film-coated tablets | 1-29517 | FY4284, GD9160, GM1341, GU1974, HA7394, HF1553, HW3573 | 1A Pharma Ltd. |
Valsartan/HCT 1A Pharma 80 mg/12.5 mg - film-coated tablets | 1-29546 | FW0324, GF4541AA, GN9218, HA3204, HV6902 | 1A Pharma Ltd. |
Valsartan/HCT 1A Pharma 160 mg/12.5 mg - film-coated tablets | 1-29547 | FT3228, FZ0848, GK6306, GT4735, GT4736, HJ6146 | 1A Pharma Ltd. |
Valsartan/HCT 1A Pharma 160 mg/25 mg - film-coated tablets | 1-29548 | FR6591, FW6899, GK6439, GU2629, GX0337, HW8597 | 1A Pharma Ltd. |
Valsartan Actavis 40 mg film-coated tablets | 1-28263 | 448815, 366116, 229317, 365317 | Actavis Group PTC ehf |
Valsartan Actavis 80 mg film-coated tablets | 1-28264 | 306115, 484015, 18816, 289816, 401916, 459016, 120617, 164717, 488317, 151118 | Actavis Group PTC ehf |
Valsartan Actavis 160 mg film-coated tablets | 1-28265 | 388215, 483915, 15816, 180716, 290016, 412316, 439216, 82517, 119817, 210017, 288417, 301717, 102618 | Actavis Group PTC ehf |
Valsartan/HCT Actavis 80 mg/12.5 mg film-coated tablets | 1-28540 | 132616, 290416, 64417, 210117, 157118 | Actavis Group PTC ehf |
Valsartan/HCT Actavis 160 mg/12.5 mg film-coated tablets | 1-28541 | 179716, 291016, 440516, 53317, 170217, 419417, 104518 | Actavis Group PTC ehf |
Valsartan/HCT Actavis 160 mg/25 mg film-coated tablets | 1-28542 | 189516, 291116, 52417, 218517, 259617 | Actavis Group PTC ehf |
Valsax 80 mg - film-coated tablets | 1-30649 | 6E152A, 6E152B, 7M161A | G.L. Pharma Ltd. |
CO-Valsax 160 mg/12.5 mg - film-coated tablets | 1-30664 | 5L170A, 5L170B, 6D195A, 6D195B, 7L283A | G.L. Pharma Ltd. |
Valsartan G.L. 80 mg - film-coated tablets | 1-30639 | 6E152A, 7M161A | G.L. Pharma Ltd. |
CO-Valsax 160 mg/25 mg - film-coated tablets | 1-30665 | 5L169A, 5L169B, 5L169C, 5L169D, 7M162A | G.L. Pharma Ltd. |
Valsax 160 mg - film-coated tablets | 1-30650 | 6C185A, 6C185B, 6K242A, 6K242B, 7F205A, 7F205B | G.L. Pharma Ltd. |
Valsartan-HCT G.L. 160 mg/25 mg - film-coated tablets | 1-30660 | 5L169A, 5L169B, 7M162A | G.L. Pharma Ltd. |
Valsartan-HCT G.L. 160 mg/12.5 mg - film-coated tablets | 1-30659 | 6D195A, 6D195B | G.L. Pharma Ltd. |
Valsartan G.L. 160 mg - film-coated tablets | 1-30645 | 6C185A, 6C185B, 7F205A | G.L. Pharma Ltd. |
CO-Valsax 80 mg/12.5 mg - film-coated tablets | 1-30663 | 5G258E, 5G258F | G.L. Pharma Ltd. |
Valsartan-HCT G.L. 80 mg/12.5 mg - film-coated tablets | 1-30658 | 5G258C, 5G258D | G.L. Pharma Ltd. |
Valsarcomp 80 mg/12.5 mg film-coated tablets | 1-30691 | All batches in the runtime | Genericon Pharma Ltd. |
Valsarcomp 160 mg/12.5 mg Film-Coated Tablets | 1-30692 | All batches in the runtime | Genericon Pharma Ltd. |
Valsarcomp 160 mg/25 mg film-coated tablets | 1-30693 | All batches in the runtime | Genericon Pharma Ltd. |
Valsarcomp 320 mg/25 mg film-coated tablets | 1-30695 | All batches in the maturity period | Genericon Pharma Ltd. |
Valsartan Genericon 80 mg film-coated tablets | 1-29606 | All batches in the maturity period | Genericon Pharma Ltd. |
Valsartan Genericon 160 mg Film-Coated Tablets | 1-29607 | All batches in the runtime | Genericon Pharma Ltd. |
Valsartan Genericon 320 mg film-coated tablets | 1-29608 | All batches in the runtime | Genericon Pharma Ltd. |
Valsartan Sandoz 80 mg - film-coated tablets | 1-29521 | FY0724, GC2270, GL0019, GT8308, HE5042, HK6314 | Sandoz Ltd. |
Valsartan Sandoz 160 mg - film-coated tablets | 1-29522 | FY4285, GF7226, GF7227, GN5277, GV7106, HC4405, HC4406, HK1606, HP1755, HW3569, HX1784 | Sandoz Ltd. |
Valsartan Sandoz 320 mg - film-coated tablets | 1-29525 | FU7037, GB1179, GM2204, GS7045, GS7046, HD4384, HN8869, HR7299, HW3942 | Sandoz Ltd. |
Valsartan/HCT Sandoz 80 mg/12.5 mg - film-coated tablets | 1-29536 | FW0323, GF4539AA, GM3629, GY4178, HD4496, HM9099, HT3701, HV8308 | Sandoz Ltd. |
Valsartan/HCT Sandoz 160 mg/12.5 mg - film-coated tablets | 1-29537 | FV4650, FV4651, GA7177, GA7178, GF7230, GS5587, HD4374, HD4375, HP4739, HU4657, HV3544 | Sandoz Ltd. |
Valsartan/HCT Sandoz 160 mg/25 mg - film-coated tablets | 1-29538 | FR6579, FW6892, GG0915, GN9236, GN9237, GY9695, HJ7757, HV2590, HW8621 | Sandoz Ltd. |
Valsartan/HCT Sandoz 320 mg/12.5 mg - film-coated tablets | 1-29539 | FS7534, FZ0871, GN9297, GY2793, HD6194, HX3936 | Sandoz Ltd. |
Valsartan/HCT Sandoz 320 mg/25 mg - film-coated tablets | 1-29540 | FZ0872, GN1123, GX2498, HJ2519, HX5680, HY2334 | Sandoz Ltd. |
Valsartan STADA 80 mg Film-Coated Tablets | 1-28990 | 70488, 73213 | STADA Arzneimittel GmbH |
Valsartan STADA 160 mg Film-coated tablets | 1-28991 | 64010V, 73338 | STADA Arzneimittel GmbH |
Valsartan STADA 320 mg Film-coated tablets | 1-28992 | 72872 | STADA Arzneimittel GmbH |
Valsartan HCT STADA 160 mg/12.5 mg Film-coated tablets | 1-29451 | 64003V, 70414 | STADA Arzneimittel GmbH |
Valsartan HCT STADA 320 mg/12.5 mg Film-coated tablets | 1-29452 | 70584, 74195 | STADA Arzneimittel GmbH |
Valsartan HCT STADA 160 mg/25 mg film-coated tablets | 1-29454 | 70716 | STADA Arzneimittel GmbH |
Valsartan HCT STADA 320 mg/25 mg film-coated tablets | 1-29455 | 65237 | STADA Arzneimittel GmbH |
Valsartan ratiopharm 40 mg Film-coated tablets | 1-29312 | 1170617, 1171220 | Teva B.V. |
Valsartan ratiopharm 80 mg film-coated tablets | 1-29313 | 1160477, 1160655, 1161124, 1170162, 1170460, 1170796, 1180144 | Teva B.V. |
Valsartan ratiopharm 160 mg film-coated tablets | 1-29315 | 1160711, 1161017, 1170174, 1170486, 1170779, 1171023 | Teva B.V. |
Valsartan ratiopharm 320 mg film-coated tablets | 1-30413 | 1160712, 1160815, 1161183, 1170618, 1170079, 1170618, 1171225 | Teva B.V. |
Valsartan/HCT ratiopharm 160 mg/12.5 mg film-coated tablets | 1-29334 | 1160462B, 1160785A, 1160785B, 1170744A, 1180128B | Teva B.V. |
Valsartan/HCT ratiopharm 320 mg/12.5 mg film-coated tablets | 1-30186 | 1160949A, 1170126C, 1170527B | Teva B.V. |
Valsartan/HCT ratiopharm 320 mg/25 mg film-coated tablets | 1-30187 | 1161142A, 1170531B | Teva B.V. |
The BASG has not received any adverse event reports from Austria for the above-mentioned drugs that are relevant to this issue.
Recommendations of the BASG
Recommendations for patients:
If you have further questions or feel unsure, please contact your physician or pharmacist.
Further Information
Official recall letters link on BASG website:
https://www.basg.gv.at/news-center/news/news-detail/article/valsartan-1250/
European Medicines Agency (EMA) Press Release:
EMA press release of 05/07/2018.
EMA press release of 17/07/2018.
Queries
Queries (technical):
Dr. Christoph Baumgärtel, Tel: +43 505 55-36004 Email: christoph.baumgaertel@ages.at
Queries (for media):
Communications Management, Tel.: +43 505 55-25000 E-mail: presse-basg@basg.gv.at