FDA-Drug2019-02-06Class II
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
Prinston Pharmaceutical Inc
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.
Sold states
Nationwide
Affected count
19800 bottles
Manufactured in
700 Atrium Dr, N/A, Somerset, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0409-2019Don't want to check this manually?
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