# FDA recall D-0146-2017

> **VistaPharm, Inc.** · Class II · drug recall initiated 2016-11-09.

## Product

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.

## Reason for recall

Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0146-2017
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-11-09
- **Report date:** 2016-11-30
- **Termination date:** 2021-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2017

## Citation

> AI Analytics. FDA recall D-0146-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0146-2017. Source: US FDA. Licensed CC0.

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