FDA-Drug2025-05-28Class II

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.

KENIL HEALTHCARE PRIVATE LIMITED
Hazard

CGMP Deviations

Sold states
DE and NC
Affected count
16,248 Jars
Manufactured in
Plot 319, Village Acharasan, Ankhol-Vamaj Road, Ta. Kadi, District Mehsana, N/A, India
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0425-2025

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