Product: 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  90 count  NDC 43547-331-09
Reason for recall: 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.
Recall initiated: 20190118
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated