Recall of drugs containing the active ingredient valsartan from the Chinese manufacturer Zhejiang Huahai Pharmaceutical

Safety warnings | Medicines | 05/07/2018

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 productMarketing Authorization NumberBatch numberMarketing Authorization Holder
Valsartan-HCT +pharma 160 mg/12.5 mg Film-Coated Tablets1-31510All batches in the runtime+pharma arzneimittel gmbh
Valsartan-HCT +pharma 80 mg/12.5 mg Film-Coated Tablets1-31509All batches in the maturity period+pharma arzneimittel gmbh
Valsartan-HCT +pharma 160 mg/25 mg film-coated tablets1-31511All batches in the maturity period+pharma arzneimittel gmbh
Valsartan +pharma 320 mg - film-coated tablets1-30679All batches in the maturity period+pharma arzneimittel gmbh
Valsartan +pharma 80 mg film-coated tablets1-30677All batches in the maturity period+pharma arzneimittel gmbh
Valsartan +pharma 160 mg film-coated tablets1-30678All batches in the maturity period+pharma arzneimittel gmbh
Valsartan 1A Pharma 80 mg - film-coated tablets1-29516GC2269, GL0015, GP1758, GX0065, HB7711, HE3808, HK6308, HV9446, HW73141A Pharma Ltd.
Valsartan 1A Pharma 160 mg - film-coated tablets1-29517FY4284, GD9160, GM1341, GU1974, HA7394, HF1553, HW35731A Pharma Ltd.
Valsartan/HCT 1A Pharma 80 mg/12.5 mg - film-coated tablets1-29546FW0324, GF4541AA, GN9218, HA3204, HV69021A Pharma Ltd.
Valsartan/HCT 1A Pharma 160 mg/12.5 mg - film-coated tablets1-29547

FT3228,

FZ0848, GK6306, GT4735, GT4736,

HJ6146

1A Pharma Ltd.
Valsartan/HCT 1A Pharma 160 mg/25 mg - film-coated tablets1-29548FR6591, FW6899, GK6439, GU2629, GX0337, HW85971A Pharma Ltd.
Valsartan Actavis 40 mg film-coated tablets1-28263

448815,

366116,

229317,

365317

Actavis Group PTC ehf
Valsartan Actavis 80 mg film-coated tablets1-28264

306115,

484015, 18816, 289816, 401916, 459016, 120617, 164717, 488317, 151118

Actavis Group PTC ehf
Valsartan Actavis 160 mg film-coated tablets1-28265

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 tablets1-28540

132616,

290416, 64417, 210117, 157118

Actavis Group PTC ehf
Valsartan/HCT Actavis 160 mg/12.5 mg film-coated tablets1-28541

179716,

291016, 440516, 53317, 170217, 419417, 104518

Actavis Group PTC ehf
Valsartan/HCT Actavis 160 mg/25 mg film-coated tablets1-28542

189516,

291116, 52417, 218517, 259617

Actavis Group PTC ehf
Valsax 80 mg - film-coated tablets1-306496E152A, 6E152B, 7M161AG.L. Pharma Ltd.
CO-Valsax 160 mg/12.5 mg - film-coated tablets1-30664

5L170A, 5L170B, 6D195A, 6D195B,

7L283A

G.L. Pharma Ltd.
Valsartan G.L. 80 mg - film-coated tablets1-306396E152A, 7M161AG.L. Pharma Ltd.
CO-Valsax 160 mg/25 mg - film-coated tablets1-306655L169A, 5L169B, 5L169C, 5L169D, 7M162AG.L. Pharma Ltd.
Valsax 160 mg - film-coated tablets1-30650

6C185A, 6C185B, 6K242A, 6K242B, 7F205A,

7F205B

G.L. Pharma Ltd.
Valsartan-HCT G.L. 160 mg/25 mg - film-coated tablets1-306605L169A, 5L169B, 7M162AG.L. Pharma Ltd.
Valsartan-HCT G.L. 160 mg/12.5 mg - film-coated tablets1-306596D195A, 6D195BG.L. Pharma Ltd.
Valsartan G.L. 160 mg - film-coated tablets1-30645

6C185A, 6C185B,

7F205A

G.L. Pharma Ltd.
CO-Valsax 80 mg/12.5 mg - film-coated tablets1-30663

5G258E,

5G258F

G.L. Pharma Ltd.
Valsartan-HCT G.L. 80 mg/12.5 mg - film-coated tablets1-306585G258C, 5G258DG.L. Pharma Ltd.
Valsarcomp 80 mg/12.5 mg film-coated tablets1-30691All batches in the runtimeGenericon Pharma Ltd.
Valsarcomp 160 mg/12.5 mg Film-Coated Tablets1-30692All batches in the runtimeGenericon Pharma Ltd.
Valsarcomp 160 mg/25 mg film-coated tablets1-30693All batches in the runtimeGenericon Pharma Ltd.
Valsarcomp 320 mg/25 mg film-coated tablets1-30695All batches in the maturity periodGenericon Pharma Ltd.
Valsartan Genericon 80 mg film-coated tablets1-29606All batches in the maturity periodGenericon Pharma Ltd.
Valsartan Genericon 160 mg Film-Coated Tablets1-29607All batches in the runtimeGenericon Pharma Ltd.
Valsartan Genericon 320 mg film-coated tablets1-29608All batches in the runtimeGenericon Pharma Ltd.
Valsartan Sandoz 80 mg - film-coated tablets1-29521FY0724, GC2270, GL0019, GT8308, HE5042, HK6314Sandoz Ltd.
Valsartan Sandoz 160 mg - film-coated tablets1-29522FY4285, GF7226, GF7227, GN5277, GV7106, HC4405, HC4406, HK1606, HP1755, HW3569, HX1784Sandoz Ltd.
Valsartan Sandoz 320 mg - film-coated tablets1-29525FU7037, GB1179, GM2204, GS7045, GS7046, HD4384, HN8869, HR7299, HW3942Sandoz Ltd.
Valsartan/HCT Sandoz 80 mg/12.5 mg - film-coated tablets1-29536FW0323, GF4539AA, GM3629, GY4178, HD4496, HM9099, HT3701, HV8308Sandoz Ltd.
Valsartan/HCT Sandoz 160 mg/12.5 mg - film-coated tablets1-29537FV4650, FV4651, GA7177, GA7178, GF7230, GS5587, HD4374, HD4375, HP4739, HU4657, HV3544Sandoz Ltd.
Valsartan/HCT Sandoz 160 mg/25 mg - film-coated tablets1-29538FR6579, FW6892, GG0915, GN9236, GN9237, GY9695, HJ7757, HV2590, HW8621Sandoz Ltd.
Valsartan/HCT Sandoz 320 mg/12.5 mg - film-coated tablets1-29539

FS7534,

FZ0871, GN9297, GY2793, HD6194, HX3936

Sandoz Ltd.
Valsartan/HCT Sandoz 320 mg/25 mg - film-coated tablets1-29540FZ0872, GN1123, GX2498, HJ2519, HX5680, HY2334Sandoz Ltd.
Valsartan STADA 80 mg Film-Coated Tablets1-28990

70488,

73213

STADA Arzneimittel GmbH
Valsartan STADA 160 mg Film-coated tablets1-28991

64010V,

73338

STADA Arzneimittel GmbH
Valsartan STADA 320 mg Film-coated tablets1-2899272872STADA Arzneimittel GmbH
Valsartan HCT STADA 160 mg/12.5 mg Film-coated tablets1-29451

64003V,

70414

STADA Arzneimittel GmbH
Valsartan HCT STADA 320 mg/12.5 mg Film-coated tablets1-29452

70584,

74195

STADA Arzneimittel GmbH
Valsartan HCT STADA 160 mg/25 mg film-coated tablets1-2945470716STADA Arzneimittel GmbH
Valsartan HCT STADA 320 mg/25 mg film-coated tablets1-2945565237STADA Arzneimittel GmbH
Valsartan ratiopharm 40 mg Film-coated tablets1-293121170617, 1171220Teva B.V.
Valsartan ratiopharm 80 mg film-coated tablets1-293131160477, 1160655, 1161124, 1170162, 1170460, 1170796, 1180144Teva B.V.
Valsartan ratiopharm 160 mg film-coated tablets1-293151160711, 1161017, 1170174, 1170486, 1170779, 1171023Teva B.V.
Valsartan ratiopharm 320 mg film-coated tablets1-304131160712, 1160815, 1161183, 1170618, 1170079, 1170618, 1171225Teva B.V.
Valsartan/HCT ratiopharm 160 mg/12.5 mg film-coated tablets1-293341160462B, 1160785A, 1160785B, 1170744A, 1180128BTeva B.V.
Valsartan/HCT ratiopharm 320 mg/12.5 mg film-coated tablets1-301861160949A, 1170126C, 1170527BTeva B.V.
Valsartan/HCT ratiopharm 320 mg/25 mg film-coated tablets1-301871161142A, 1170531BTeva 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 07/05/2018.

EMA press release of 07/17/2018.

Queries (technical):

Dr. Christoph Baumgärtel, Tel: +43 505 55-36004 Email:

Queries (for media):

Communications Management, Tel.: +43 505 55-25000 E-mail: presse-basg@basg.gv.at

Email

Further inquiry note