# FDA recall D-1059-2017

> **X-Gen Pharmaceuticals Inc.** · Class II · drug recall initiated 2017-05-17.

## Product

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

## Reason for recall

Presence of Foreign Substance:  potential presence of plastic particles.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-1059-2017
- **Recalling firm:** X-Gen Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-17
- **Report date:** 2017-08-16
- **Termination date:** 2018-09-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horseheads, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2017

## Citation

> AI Analytics. FDA recall D-1059-2017. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1059-2017. Source: US FDA. Licensed CC0.

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