Edge Pharma recalls CSF-HC Otic Insufflation Capsule powder for potential manufacturing deviations. Affected products include 50mg/30mg/25mg/5mg bottles with specific NDC numbers and dates.
CGMP Deviations
Edge Pharma is recalling a specific otic powder product due to manufacturing deviations. This recall is important because it addresses potential quality issues that could affect product safety.
The recall is for manufacturing deviations (CGMP deviations), which means the product may not meet quality standards. This could potentially lead to safety issues, but the exact risk is not specified in the recall notice.
People who own or use the recalled CSF-HC Otic Insufflation Capsule powder for ear infections are affected. Those with the specific NDC numbers and purchase dates listed are most at risk.
Check for the 50mg/30mg/25mg/5mg bottle with 5 count. The product was sold with NDC 05446-1634-01 between January 2022 and April 2022.
Look for the NDC number 05446-1634-01 on the bottle label.
The recall states there were manufacturing deviations, but does not specify if the product is unsafe. The official notice does not provide details on the exact risk.
The recall does not provide a remedy, so no specific action is required beyond checking if you have the product.
The product was recalled with specific dates in the notice: January 2022 and April 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-0432-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0432-2022 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.
