Drug & medication recalls Moderate risk

CURA HONGOS recalled over manufacturing violations

Recall date
April 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
KENIL HEALTHCARE PRIVATE LIMITED recalls CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New…
Recall number
D-0422-2025
FDA classification
Class II
Brand / firm
KENIL HEALTHCARE PRIVATE LIMITED
Sold / distributed
DE and NC

Why it was recalled

CGMP Deviations

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

What was recalled

CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.

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