US Drug Recall Register
Class II · Moderate risk Completed Initiated Jan 18, 2019 (8 years ago)

Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

What was recalled

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

Recalling firm
Prinston Pharmaceutical Inc
NDC code
43547-376-09
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0409-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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