D-0422-2025 Class II Terminated
FDA drug recall D-0422-2025 was initiated by KENIL HEALTHCARE PRIVATE LIMITED on April 24, 2025 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated February 19, 2026). Affected quantity: 10,128 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2025
- Initiation Date
- April 24, 2025
- Termination Date
- February 19, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,128 Bottles
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
Distribution Pattern
DE and NC
Code Information
Lot SP31A, Exp Date: 09/30/2026