# FDA recall D-0869-2017

> **VistaPharm, Inc.** · Class III · drug recall initiated 2017-05-17.

## Product

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.

## Reason for recall

Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

## Distribution

Nationwide in the US and Puerto Rico

## Key facts

- **Recall number:** D-0869-2017
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-17
- **Report date:** 2017-06-07
- **Termination date:** 2020-01-13

- **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-0869-2017

## Citation

> AI Analytics. FDA recall D-0869-2017. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/D-0869-2017. Source: US FDA. Licensed CC0.

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