Reported Aug 16, 2017 · Terminated

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

X-Gen Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Dr · Horseheads, NY · 14845-1014

Is this the product you have?

  • Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Lot codes and dates
    • Lot #: 23701.158A
    • EXP 10/31/18
Amount recalled
9,816 bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance: potential presence of plastic particles.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 5, 2018 · Data as of Sep 19, 5:02 PM UTC

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