D-0410-2019 Class II
FDA drug recall D-0410-2019 was initiated by Prinston Pharmaceutical Inc on January 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 par… Affected quantity: 2177 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 6, 2019
- Initiation Date
- January 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2177 bottles
Product Description
Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg Rx Only 90 count Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-330-09
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
325B18004