FDA recall D-0426-2025

KENIL HEALTHCARE PRIVATE LIMITED · Class II · drug

Product

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

Distribution

DE and NC

Key facts

Status: Terminated
Initiation date: 2025-04-24
Report date: 2025-05-28
Termination date: 2026-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ta. Kadi, District Mehsana, N/A, India

Primary source

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