# FDA recall D-0019-2021

> **VistaPharm, Inc.** · Class III · drug recall initiated 2020-09-25.

## Product

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)  Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

## Reason for recall

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

## Distribution

Distributed Nationwide in the USA including Puerto Rico

## Key facts

- **Recall number:** D-0019-2021
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-25
- **Report date:** 2020-10-14
- **Termination date:** 2022-09-28

- **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-0019-2021

## Citation

> AI Analytics. FDA recall D-0019-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/D-0019-2021. Source: US FDA. Licensed CC0.

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