# FDA recall D-0968-2018

> **Prinston Pharmaceutical Inc** · Class II · drug recall initiated 2018-07-13.

## Product

Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- 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 43547-367-03

## Reason for recall

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

## Distribution

United States

## Key facts

- **Recall number:** D-0968-2018
- **Recalling firm:** Prinston Pharmaceutical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2018-07-13
- **Report date:** 2018-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cranbury, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0968-2018

## Citation

> AI Analytics. FDA recall D-0968-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0968-2018. Source: US FDA. Licensed CC0.

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