# FDA recall D-1053-2017

> **VistaPharm, Inc.** · Class II · drug recall initiated 2017-06-26.

## Product

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case,  Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

## Reason for recall

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

## Distribution

CA, IL, LA, NH, OH, PA, SC

## Key facts

- **Recall number:** D-1053-2017
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-06-26
- **Report date:** 2017-08-09
- **Termination date:** 2019-04-03

- **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-1053-2017

## Citation

> AI Analytics. FDA recall D-1053-2017. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-1053-2017. Source: US FDA. Licensed CC0.

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