Drug product

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 30 count - NDC 43547-331-03

D-0411-2019

January 18, 2019

Class II

Product summary

Firm: Prinston Pharmaceutical Inc
Event: Event 81910
Status: Completed
Classification: Class II
Quantity: 32692 bottles
Official record key: drug-enforcement:D-0411-2019

Official wording

Reason: 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.

Code information: 327A18001 327A18002

Distribution pattern: Nationwide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations