Class II

Drug Recall: 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 55758-10

KENIL HEALTHCARE PRIVATE LIMITED · April 24, 2025

Reason for Recall

CGMP Deviations

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.

Distribution

DE and NC

States Affected

DE, NC

Quantity Affected

11,808 Jars

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0426-2025

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.