← FDA ENFORCEMENT
D-0423-2025Class 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
10,788 Tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.

Code / lot info

Lot SP23A, Exp Date: 03/31/2026

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.