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DRUGS. ANSM (The National Agency for the Safety of Medicines and Health Products) has been informed of a quality defect affecting certain specialties based on valsartan and valsartan / hydrochlorothiazide, used in heart failure, in hypertension arterial and post myocardial infarction. It is an impurity found in the active substance manufactured by the Chinese company Zhejiang Huahai Pharmaceuticals. This impurity is N-nitrosodimethylamine (NDMA), a substance clbadified as probably carcinogenic in humans, which appeared during the manufacture of the active substance.
The laboratories (Arrow Generics, Biogaran, Cristers, Eg Labo, EvoluPharm, Ranbaxy, Sandoz, Zentiva, Zydus) therefore recalled the lots affected by this defect
The Member States of the European Union decided collectively and in a concerted manner to recall the lots of the specialties affected by this defect on the whole. European territory. In this context, the laboratories, in agreement with the ANSM, have made a recall to pharmacies, wholesaler-distributors and French hospital pharmacies of the specialties potentially affected by this defect.
The other specialties containing valsartan or other medicinal products the same therapeutic clbad (other sartans) are not concerned and remain available. ANSM is in contact with the laboratories to guarantee the market supply of specialties not affected by this defect. Patients treated with one of the impacted valsartan specialties should not stop their treatment on their own or return their boxes to the pharmacy.
In the next issue, the pharmacist will offer one of the specialties to base of valsartan not concerned by this defect. The investigation of the quality defect is ongoing at the European level. The ANSM is waiting for the definitive badysis of the impact of the presence of this impurity.
The Agence du médicament claims that there is no acute risk for the patient.
About 1.3 million people are affected in France overseas included. For any questions, patients may contact their doctor or pharmacist.
Here is the list of Valsartan and Valsartan Hydrochlorothiazide proprietary medicinal products impacted by batch recall:
– ARROW GENERIC LABORATORY
VALSARTAN Actavis 160mg scored film-coated tablet; VALSARTAN Actavis 80mg film-coated tablet scored; VALSARTAN HCTZ Arrow lab 160mg / 12.5mg film-coated tablet; VALSARTAN HCTZ Arrow Lab 160mg / 25mg film-coated tablet; VALSARTAN HCTZ Arrow lab 80mg / 12.5mg film-coated tablet
-LABORATORY BIOGARAN
VALSARTAN BIOGARAN 40 mg film-coated tablets scored; VALSARTAN BIOGARAN 80 mg scored film-coated tablet; VALSARTAN BIOGARAN 160 mg scored film-coated tablet; VALSARTAN HCTZ BIOGARAN 80 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ BIOGARAN 160 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ BIOGARAN 160 mg / 25 mg film-coated tablet
-LABORATORY CRISTERS
VALSARTAN CRISTERS 40mg film-coated tablet scored; VALSARTAN CRISTERS 80mg film-coated tablet scored; VALSARTAN CRISTERS 160mg film-coated tablet scored; VALSARTAN HCTZ CRISTERS 80mg / 12,5mg film-coated tablet; VALSARTAN HCTZ CRISTERS 160mg / 12,5mg film-coated tablet; VALSARTAN HCTZ CRISTERS 160mg / 25mg film-coated tablet
-LAMBO LABORATORY
Only the lots mentioned below are concerned:
-VALSARTAN EG 40 mg tablets scored films: lots 64830, 72939, 72940;
-VALSARTAN EG 80 mg film-coated tablet scored: lots 65182, 65183, 65184, 65185, 65186, 65187, 70790, 72498, 72499, 73001, 73002, 73003, 73004, 74421 , 74422 VALSARTAN EG 160 mg film-coated tablet scored: lots 70416, 73130, 73131, 74245, 81350
-VALSARTAN HCTZ EG 80 mg / 12.5 mg film-coated tablets: lots 70341, 81153; VALSARTAN HCTZ EG 160 mg / 12.5 mg film-coated tablet: lbots 70410, 73420
-VALSARTAN HCTZ EG 160 mg / 25 mg, film-coated tablet: lots 63977V, 63978, 73389, 74195, 74196, 81202
-LABORATORY EVOLUPHARM
-VALSARTAN 40mg EVOLUGEN film-coated tablet scored VALSARTAN 80mg EVOLUGEN film-coated tablet scored
-VALSARTAN 160mg EVOLUGEN film-coated tablet scored; VALSARTAN HCTZ 80mg / 12,5mg EVOLUGEN film-coated tablets; VALSARTAN HCTZ 160mg / 12,5mg -EVOLUGEN film-coated tablet; VALSARTAN HCTZ 160mg / 25mg EVOLUGEN film-coated tablet
RANBAXY LABORATORY GENERIC PHARMACY
VALSARTAN HCTZ RANBAXY 80 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ RANBAXY 160 mg / 25 mg film-coated tablets; VALSARTAN HCTZ RANBAXY 160 mg / 12.5 mg film-coated tablet
SANDOZ LABORATORY
VALSARTAN SANDOZ 40 mg scored film-coated tablet; VALSARTAN SANDOZ 80 mg film-coated tablets; VALSARTAN SANDOZ 160 mg film-coated tablets; VALSARTAN HCTZ SANDOZ 80 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ SANDOZ 160 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ SANDOZ 160 mg / 25 mg film-coated tablets
ZENTIVA LABORATORY:
VALSARTAN ZENTIVA 40 mg film-coated tablets scored; VALSARTAN ZENTIVA 80 mg film-coated tablets; VALSARTAN ZENTIVA 160 mg film-coated tablets; VALSARTAN HCTZ ZENTIVA LAB 80 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ ZENTIVA LAB 160 mg / 12.5 mg film-coated tablets; VALSARTAN HCTZ ZENTIVA LAB 160 mg / 25 mg film-coated tablet
ZYDUS LABORATORY
Valsartan Zydus France 80 mg scored film-coated tablet; Valsartan Zydus France 160 mg film-coated tablets scored; Valsartan Zydus France 40 mg scored film-coated tablet; Valsartan / HCTZ Zydus 80 mg / 12.5 mg film-coated tablets; Valsartan / HCTZ Zydus 160 mg / 25 mg film-coated tablets; Valsartan / HCTZ Zydus 160 mg / 12.5 mg film-coated tablet
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