Home / Recalls / Prinston Pharmaceutical Inc / D-0974-2018

D-0974-2018 Class II Ongoing

Recalled by Prinston Pharmaceutical Inc — Cranbury, NJ

FDA drug recall D-0974-2018 was initiated by Prinston Pharmaceutical Inc on Jul 13, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. The recall status is ongoing.

Recall Details

Product Type: Drugs
Report Date: Aug 1, 2018
Initiation Date: Jul 13, 2018
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-313-09

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

United States

Code Information

All lots within expiry

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0974-2018
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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