Edge Pharma recalls sterile phenylephrine injection due to lack of assurance of sterility. Affected units sold from 2021-2022; consumers should contact Edge Pharma for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific phenylephrine injection product because it may not be sterile. This could lead to infections if used improperly. The recall affects certain batches sold between December 2021 and February 2022.
The product lacks assurance of sterility, meaning it could contain harmful bacteria or other contaminants. If injected into the bloodstream, this could cause serious infections or other health issues.
Healthcare professionals using this injection for IV procedures are most at risk. Patients receiving this medication through IV lines may also be affected.
Check for the product name 'Phenylephrine HCl, Sterile Solution for Injection' with NDC 05446-1652-01. This product was sold between December 2021 and February 2022.
Reach out to Edge Pharma at 856 Hercules Dr., Colchester, VT 05446 for specific instructions on handling the recalled product.
The recall indicates a lack of assurance of sterility, so it is not safe to use as the product may contain harmful contaminants.
Contact Edge Pharma directly for specific instructions on handling the recalled product.
This product was recalled starting in December 2021 and continued through February 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-0417-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0417-2022 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.
