Drug & medication recalls Moderate risk

X-Gen Pharmaceuticals Inc. recalls Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

Recall date
May 17, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1059-2017
FDA classification
Class II
Brand / firm
X-Gen Pharmaceuticals Inc.
Sold / distributed
Nationwide in the US

Why it was recalled

Presence of Foreign Substance: potential presence of plastic particles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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