Edge Pharma recalls 50mg/30mg/5mg sulfacetamide ciprofloxacin amphotericin B otic powder due to manufacturing deviations. No specific remedy stated in recall notice.
CGMP Deviations
Edge Pharma is recalling a specific otic powder product due to manufacturing deviations. This recall does not include a remedy or action for consumers.
The product was made under CGMP (Current Good Manufacturing Practices) deviations, which means the manufacturing process did not meet safety standards. This could potentially lead to unsafe medication quality, but the exact risk is not specified in the recall.
People who own or use the recalled CSF Otic Insufflation Capsule powder for ear treatment. Those with ear infections requiring this medication are most at risk.
The product is a 5-count bottle labeled 'CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg'. It was sold from October 2021 to January 2022 with NDC 05446-1633-05.
Look for the product name and NDC code 05446-1633-05 on the bottle label.
The recall mentions CGMP deviations but does not specify if the product could cause serious injury.
The recall does not provide a remedy or action for consumers.
The product was sold from October 2021 to January 2022.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0431-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0431-2022 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.
