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 #: 23701.158AEXP 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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