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FDAJanuary 18, 2019drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Completed

Brands named

prinston pharmaceuticalprinston

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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