Edge Pharma recalls 0.4% Dexamethasone sodium phosphate topical cream due to CGMP deviations. Affected units may have quality issues affecting safety.
CGMP Deviations
Edge Pharma is recalling a topical dexamethasone cream because of manufacturing quality control issues. This could affect product safety, though the specific risk isn't detailed in the recall.
CGMP deviations mean the product may not meet quality standards during manufacturing. This could lead to inconsistent potency or safety issues, but the exact risk isn't specified in the recall.
People who own or use this specific topical cream for skin conditions. Those with sensitive skin or using it for extended periods may be at higher risk.
Check for the product name 'Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use' from Edge Pharma. The NDC code 05446-0622-01 is also listed.
Look for the product name and NDC code 05446-0622-01 on the label.
The recall states CGMP deviations but does not specify if the product is dangerous or the exact risk.
Check for the product name and NDC code 05446-0622-01 on the label.
The recall does not provide specific action steps beyond checking product details.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0433-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0433-2022 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.
