Edge Pharma recalls BLT Topical Cream (20%/8%/4% Benzocaine/Lidocaine/Tetracaine) due to CGMP deviations. Consumers should check NDC 05446-1235-01 for affected products.
CGMP Deviations
Edge Pharma is recalling BLT Topical Cream products that contain Benzocaine, Lidocaine, and Tetracaine due to manufacturing quality control issues. This recall does not involve a specific safety hazard but addresses potential product quality problems.
CGMP deviations refer to failures in the manufacturing process that could affect product quality. While this does not indicate a direct safety hazard like injury or illness, it means the product may not meet the required quality standards for consistent effectiveness.
People who own or use the BLT Topical Cream (20%/8%/4% Benzocaine/Lidocaine/Tetracaine, 60g jars) with NDC 05446-1235-01 are affected. Those using topical anesthetics for pain relief or minor injuries may be at slightly higher risk due to potential quality issues.
Check for the NDC code 05446-1235-01 on the product label. The product is a 60g multiple-dose container of BLT Topical Cream containing 20% Benzocaine, 8% Lidocaine, and 4% Tetracaine.
Look for the NDC code 05446-1235-01 on the BLT Topical Cream container to confirm if it is affected.
The recall is due to CGMP deviations, which means potential quality issues but not a direct safety hazard like injury or illness. The product is still safe for use as intended.
Check the product label for the NDC code 05446-1235-01. If it matches, contact Edge Pharma for further instructions.
The recall record does not specify a replacement option. Consumers should check with Edge Pharma directly for guidance.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0428-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0428-2022 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.
