Edge Pharma recalls sterile dexamethasone otic solution due to lack of assurance of sterility. This may cause infections if used improperly. Affected products were sold from 2021-2022.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific dexamethasone otic solution product because it may not be sterile. Using this product could lead to infections, especially if it's not properly handled.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. If used for ear injections, this might cause infections or other complications.
People who have purchased this specific dexamethasone otic solution for ear injections. Those with compromised immune systems or open wounds may be at higher risk of infection.
Check for the product name 'Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe'. It was sold by Edge Pharma LLC from 2021-2022.
Look for the product name and NDC code 05446-0848-01 on the syringe label.
The recall states there is a lack of assurance of sterility, so it may not be safe. Do not use this product.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance.
This product was sold from 2021-2022 as indicated 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-0399-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0399-2022 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.
