Recall
FDAHealthApril 24, 2025

KENIL HEALTHCARE PRIVATE LIMITED — KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC,

⚠️ CGMP Deviations

Is this relevant to me?

Geography
DE, NC
Source agency
FDA
Category
Health
Published
April 24, 2025

DE and NC

What's affected?

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.
Brand
KOFAL
UPC
899711001013
Lot code
P30A

Additional details

Lot SP30A, Exp Date: 09/30/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 11,808 Jars.

View original FDA notice →

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