KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - ...
FDA Recall #D-0426-2025 — Class II — April 24, 2025
Product Description
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.
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
11,808 Jars
Distribution
DE and NC
Code Information
Lot SP30A, Exp Date: 09/30/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated