Edge Pharma recalls 4%/1% nasal solution due to CGMP deviations. Affected products have NDC 05446-1045-03. Consumers should contact Edge Pharma for details.
CGMP Deviations
Edge Pharma is recalling nasal solution products that may have manufacturing deviations. This could affect product safety and quality, though the specific risk isn't detailed in the recall notice.
CGMP deviations refer to manufacturing process issues that could affect product quality and safety. However, the recall notice does not specify the exact nature of the deviations or the potential risks.
People who own or use the recalled nasal solution products. Those with specific medical conditions or using the product for nasal congestion may be at higher risk.
Check for the product name 'Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle' with NDC 05446-1045-03. The product was sold between July 2021 and March 2022.
Look for the NDC code 05446-1045-03 on the product label.
The recall mentions CGMP deviations, but does not specify the exact hazard or risk.
Check for the NDC code 05446-1045-03 on the product label. The product was sold between July 2021 and March 2022.
The recall does not specify a remedy, so contact Edge Pharma directly for instructions.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0444-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0444-2022 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.
