Drug & medication recalls Moderate risk

KOFAL Original recalled over manufacturing violations

Recall date
April 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
KENIL HEALTHCARE PRIVATE LIMITED recalls KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Dist…
Recall number
D-0425-2025
FDA classification
Class II
Brand / firm
KENIL HEALTHCARE PRIVATE LIMITED
Sold / distributed
DE and NC

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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