D-0412-2019 Class II
FDA drug recall D-0412-2019 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: 12294 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 6, 2019
- Initiation Date
- Jan 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12294 bottles
Product Description
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.
Distribution Pattern
Nationwide
Code Information
327B18008 327B18009
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0412-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026