Edge Pharma recalls phenol topical solution vials due to CGMP deviations. These vials may not meet safety standards. Consumers should check product details and contact Edge Pharma for guidance.
CGMP Deviations
Edge Pharma is recalling phenol topical solution vials (89%, 3mL) because of manufacturing quality control issues. This could mean the product doesn't meet safety standards, potentially causing harm if used improperly.
CGMP deviations refer to failures in the manufacturing process that could affect product safety and quality. Phenol is a strong chemical that can cause skin irritation or injury if not handled properly. Without proper quality control, the product might not be safe for use.
People who own or use phenol topical solution vials with the specific NDC number 05446-1211-03 are affected. Those using the product for medical purposes may be at higher risk due to the nature of the product.
Check for the NDC number 05446-1211-03 on the vial label. The product was sold between July 2021 and October 2021 in specific batches.
Look for the NDC number 054446-1211-03 on the vial label to confirm if it's recalled.
The recall is due to CGMP deviations, which means the product may not meet safety standards. Edge Pharma has not provided specific details on the exact risk.
The recall record does not mention any remedy or replacement options.
The product was sold between July 2021 and October 2021 in specific batches.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0443-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0443-2022 from Edge Pharma. 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.
