Product: Irbesartan Tablets 300 mg 90 count  Rx only    Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang  317024 China     Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512   NDC 43547-376-09
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