# FDA recall D-1377-2020

> **VistaPharm, Inc.** · Class III · drug recall initiated 2020-06-23.

## Product

Nystatin Oral Suspension, USP 500,000 units/5mL Cup,  Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

## Reason for recall

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

## Distribution

United States including Puerto Rico

## Key facts

- **Recall number:** D-1377-2020
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-23
- **Report date:** 2020-07-15
- **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-1377-2020

## Citation

> AI Analytics. FDA recall D-1377-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1377-2020. Source: US FDA. Licensed CC0.

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