Edge Pharma recalls Profound-PE Dental Gel due to CGMP deviations. This dental gel may not meet safety standards. Consumers should check product details and contact Edge Pharma for updates.
CGMP Deviations
Edge Pharma is recalling Profound-PE Dental Gel because of manufacturing quality control issues. This recall affects dental products that may not meet safety standards, potentially putting users at risk.
CGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. This means the dental gel might not meet the required safety standards for use in dentistry.
Dentists and dental patients who use Profound-PE Dental Gel are affected. Those with the specific product codes listed in the recall are most at risk.
Check for the product name 'Profound-PE Dental Gel' with the NDC code 05446-1018-10. The recall includes specific batch numbers and dates listed in the notice.
Look for the NDC code 05446-1018-10 on the product label to confirm if it's recalled.
The recall indicates potential manufacturing issues, but the official notice does not specify if the product is safe to use.
Check the product label for the NDC code 05446-1018-10 and compare it with the list of recalled batch numbers provided in the recall notice.
The recall notice does not specify a remedy, so contact Edge Pharma directly for further instructions.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0441-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0441-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
