# FDA recall D-1049-2016

> **Prinston Pharmaceutical Inc** · Class III · drug recall initiated 2016-05-30.

## Product

Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ  08512, NDC 43547-331-09.

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1049-2016
- **Recalling firm:** Prinston Pharmaceutical Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-30
- **Report date:** 2016-06-29
- **Termination date:** 2017-06-09

- **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-1049-2016

## Citation

> AI Analytics. FDA recall D-1049-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1049-2016. Source: US FDA. Licensed CC0.

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