Irbesartan and Hydrochlorothiazide Tablets recalled over manufacturing violations

Recall date

January 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Prinston Pharmaceutical Inc recalls Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.…

Recall number

D-0411-2019

FDA classification

Class II

Brand / firm

Prinston Pharmaceutical Inc

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zheijang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 30 count - NDC 43547-331-03