# FDA recall D-0410-2019

> **Prinston Pharmaceutical Inc** · Class II · drug recall initiated 2019-01-18.

## Product

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

Nationwide

## Key facts

- **Recall number:** D-0410-2019
- **Recalling firm:** Prinston Pharmaceutical Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2019-01-18
- **Report date:** 2019-02-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0410-2019

## Citation

> AI Analytics. FDA recall D-0410-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0410-2019. Source: US FDA. Licensed CC0.

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