CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/po...
FDA Recall #D-0422-2025 — Class II — April 24, 2025
Product Description
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.
Reason for Recall
CGMP Deviations
Recalling Firm
KENIL HEALTHCARE PRIVATE LIMITED — Ta. Kadi, District Mehsana, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10,128 Bottles
Distribution
DE and NC
Code Information
Lot SP31A, Exp Date: 09/30/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated