Edge Pharma recalls LET Topical Gel (4%/0.05%/0.5%) due to CGMP deviations. Affected units sold from 2021-07 to 2022-03. No remedy specified in recall notice.
CGMP Deviations
Edge Pharma is recalling a topical gel containing lidocaine, epinephrine, and tetracaine for potential CGMP deviations. This recall affects specific batches sold between July 2021 and March 2022. The product's safety is not guaranteed due to manufacturing issues.
CGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. The specific issue with this gel might result in inconsistent quality or safety, though the exact hazard isn't detailed in the recall notice.
Users of the LET Topical Gel with NDC 05446-0607-01 who purchased it between July 2021 and March 2022 are affected. People using this gel for medical purposes may be at risk due to potential manufacturing issues.
Check for the NDC code 05446-0607-01 on the product label. The gel was sold by Edge Pharma from July 2021 through March 2022.
Look for the NDC code 05446-0607-01 on the gel's packaging to confirm if it's affected.
The recall notice states there were CGMP deviations, but does not specify if the product is safe. Edge Pharma has recalled it due to potential manufacturing issues.
The recall notice does not provide a remedy, so no specific action is required beyond checking if you have the affected batch.
The product was sold from July 2021 through March 2022, as indicated by the NDC codes and dates in the recall notice.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0437-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0437-2022 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.
