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API Impurity Prompts Recall


August 02, 2018

Teva Pharmaceuticals USA is voluntarily recalling multiple lots of valsartan and valsartan-hydrochlorothiazide tablets after a carcinogen impurity was detected in an active pharmaceutical ingredient (API) used to manufacture the drug, according to the August 1, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The affected tablets were manufactured by Arrow Pharma (Malta) Ltd. in India and distributed throughout the United States, including Hawaii and Puerto Rico, by Actavis Pharma Inc.

The recall includes the following:

  • valsartan tablets, USP, 320 mg, 90-count bottle (NDC 0591-2170-19), from lots 1208002A, 1247282M, and 1263944M;
  • valsartan tablets, USP, 320 mg, 500-count bottle (NDC 0591-2170-05), from lots 1208000M, 1208001M, and 1240425A;
  • valsartan tablets, USP, 160 mg, 90-count bottle (NDC 0591-2169-19), from lots 1177880A, 1220831A, and 1263941A;
  • valsartan tablets, USP, 160 mg, 1000-count bottle (NDC 0591-2169-10), from lots 1175922M, 1220826M, 1236294M, 1240427M, and 1270616A;
  • valsartan tablets, USP, 80 mg, 90-count bottle (NDC 0591-2168-19), from lots 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, and 1250704M;
  • valsartan tablets, USP, 80 mg, 1000-count bottle (NDC 0591-2168-10), from lots 1177114A, 1219360M, and 1250706A;
  • valsartan tablets, USP, 40 mg, 30-count bottle (NDC 0591-2167-30), from lots 1196936A, 1238463A, and 1270617A;
  • valsartan tablets, USP, 40 mg, 90-count bottle (NDC 0591-2167-19), from lots 1196934M, 1238462M, and 1268429A;
  • valsartan and hydrochlorothiazide tablets, USP, 320 mg/25 mg, 90-count bottle (NDC 0591-2318-19), from lots 1191188M, 1191189M, 1191190M, 1199220M, 1217576M, 1217577M, 1217578M, 1220832M, 1220833M, 1247283M, 1247284M, 1247285M, 1247286M, 1247287A, 1280632M, and 1280633M;
  • valsartan and hydrochlorothiazide tablets, USP, 320 mg/12.5 mg, 90-count bottle (NDC 0591-2318-19), from lots 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, and 1253257M;
  • valsartan and hydrochlorothiazide tablets, USP, 160 mg/25 mg, 90-count bottle (NDC 0591-2317-19), from lots 1191164M, 1191165M, 1191166M, 1191167A, 1225612M, 1250717M, 1256111M, and 1288798M;
  • valsartan and hydrochlorothiazide tablets, USP, 160 mg/12.5 mg, 90-count bottle (NDC 0591-2316-19), from lots 1191160M, 1191161M, 1191162A, 1219363M, 1219364M, 1219365A, 1225613A, 1233944M, 1233945M, 1253253M, and 1253254M; and
  • valsartan and hydrochlorothiazide tablets, USP, 80 mg/12.5 mg, 90-count bottle (NDC 0591-2315-19), from lots 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M 1256125M, and 1277709M.

Teva Pharmaceuticals initiated the recall July 16, 2018. On July 24, 2018, the FDA designated the recall Class II, which suggests use of affected tablets poses the possibility of temporary or medically reversible adverse health consequences and, while remote, a possibility of serious harm.

Valsartan is a prescription angiotensin receptor blocker used for the treatment of high blood pressure and congestive heart failure. Valsartan-hydrochlorothiazide is used for the treatment of high blood pressure.

Jolynn Tumolo


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