KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), ...
FDA Recall #D-0425-2025 — Class II — April 24, 2025
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
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
16,248 Jars
Distribution
DE and NC
Code Information
Lost SP21A, Exp Date: 03/31/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated