August 02, 2018
Prinston Pharmaceutical Inc. is recalling Solco Healthcare US valsartan and valsartan-hydrochlorothiazide tablets because a carcinogen impurity was detected in an active pharmaceutical ingredient (API) used to manufacture the drug. The voluntary recall was included in the August 1, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects unexpired 90-count bottles of Solco Healthcare US valsartan, USP, 320 mg (NDC 43547-370-09), 160 mg (NDC 43547-369-09), and 80 mg (NDC 43547-368-09). Also included are unexpired 30-count bottles of 40 mg Solco Healthcare US valsartan (NDC 43547-367-03).
In addition, all unexpired 90-count bottles of Solco Healthcare US valsartan and hydrochlorothiazide, USP, 320 mg/25 mg (NDC 43547-315-09), 320 mg/12.5 mg (NDC 43547-314-09), 160 mg/25 mg (NDC 43547-313-09), 160 mg/12.5 mg (NDC 43547-312-09), and 80 mg/12.5 mg are being recalled.
The recalled valsartan and valsartan-hydrochlorothiazide tablets were manufactured by Zhejiang Huahai Pharmaceutical Co. in China and distributed in the United States by Solco Healthcare US.
Prinston Pharmaceuticals initiated the recall July 13, 2018. The FDA designated the recall Class II July 20, 2018. Drugs included in Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Valsartan is a prescription angiotensin receptor blocker used to treat patients with high blood pressure and congestive heart failure. Valsartan-hydrochlorothiazide is a combination tablet used to treat high blood pressure.
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