FDA-Drug2025-05-28Class II

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.

KENIL HEALTHCARE PRIVATE LIMITED
Hazard

CGMP Deviations

Sold states
DE and NC
Affected count
11,808 Jars
Manufactured in
Plot 319, Village Acharasan, Ankhol-Vamaj Road, Ta. Kadi, District Mehsana, N/A, India
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2025

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