D-0425-2025 Class II Terminated
FDA drug recall D-0425-2025 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: 16,248 Jars.
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
- 16,248 Jars
Product Description
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
Reason for Recall
CGMP Deviations
Distribution Pattern
DE and NC
Code Information
Lost SP21A, Exp Date: 03/31/2026