Kofal Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) with CGMP deviations is being recalled. This recall affects 4 oz jars distributed by Pharmadel LLC. Consumers should check NDC 55758-106-04 for affected products.
CGMP Deviations
Kofal's Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) is being recalled due to manufacturing deviations. This could affect product safety and quality, though the specific risk isn't detailed in the recall notice.
The recall mentions CGMP deviations, which are manufacturing quality control issues. These deviations could lead to product safety or quality problems, but the specific hazard isn't described in the notice.
Owners of the 4 oz jar of Kofal Original Pain Relieving Ointment with NDC 55758-106-04 are affected. People using topical pain relievers for conditions like muscle or joint pain are most at risk.
Check for the 4 oz jar labeled 'KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12%)'. The product has NDC 55758-106-04 and was distributed by Pharmadel LLC.
Look for the NDC code 55758-106-04 on the jar to confirm if it's affected.
The recall states there were CGMP deviations, but the specific safety risk isn't detailed in the notice.
Check for the NDC code 55758-106-04 on the jar, which was distributed by Pharmadel LLC.
The recall doesn't specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Kofal to request your refund or repair — edit it as you like.
Subject: Recall D-0425-2025 — Kofal Kofal Hello, I own a Kofal that is covered by recall D-0425-2025 from Kofal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
