D-0409-2019 Class II
FDA drug recall D-0409-2019 was initiated by Prinston Pharmaceutical Inc on Jan 18, 2019 and is designated Class II. 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… Affected quantity: 19800 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 6, 2019
- Initiation Date
- Jan 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19800 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
331B18009
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0409-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026