January 19, 2018
Prinston Pharmaceutical Inc. is recalling 90-count bottles of valsartan tablets, USP, 160 mg (NDC 43547-369-09), after a customer reported tablets that were thicker and heavier than normal, according to the January 17, 2018, US Food and Drug Administration (FDA) Enforcement Report.
Nearly 22,000 bottles from lot 343B17025 (Exp. 3/31/19) are included in the recall. Manufactured by Zhejiang Huahai Pharmaceutical Co., the tablets were distributed across the United States and in Puerto Rico by Solco Healthcare US.
The valsartan recall was voluntarily initiated by Prinston Pharmaceutical November 27, 2017. On January 8, 2018, the FDA designated the recall Class II. The classification suggests use of the affected tablets could cause temporary or reversible adverse effects with a remote probability of serious harm.
Valsartan is a prescription drug used to treat high blood pressure and heart failure.
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