Edge Pharma recalls 4% Lidocaine / 0.05% Oxymetazoline nasal solution due to CGMP deviations. No specific remedy stated in recall notice.
CGMP Deviations
Edge Pharma is recalling a nasal spray product that may have manufacturing issues. This recall is for safety reasons related to quality control failures, though no specific harm has been reported.
The product was manufactured under CGMP (Current Good Manufacturing Practices) deviations, which means the quality control process failed. This could lead to potential safety issues with the medication, though the exact risk is not specified in the recall notice.
People who own or use the recalled nasal solution from Edge Pharma. Those with the specific product code (NDC 05446-1256-01) are most at risk.
Check for the product name: Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle. Look for the NDC code 05446-1256-01 on the label or packaging.
Look for the NDC code 05446-1256-01 on the label or packaging to confirm if the product is recalled.
The recall notice does not state any remedy or action required for consumers.
The product NDC code is 05446-1256-01.
The product was manufactured between July 7, 2021, and October 21, 2021, based on the recall dates.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0438-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0438-2022 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.
