← FDA ENFORCEMENT
D-0422-2025Class II

KENIL HEALTHCARE PRIVATE LIMITED

Recalling firm
KENIL HEALTHCARE PRIVATE LIMITED
Product type
Drug
Status
Terminated
Report date
2025-05-28
Distribution
DE and NC
Firm state
N/A
Product quantity
10,128 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

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.

Code / lot info

Lot SP31A, Exp Date: 09/30/2026

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.