Edge Pharma recalls 5mL single-use IV syringes for phenylephrine HCl 0.5mg/5mL due to lack of sterility assurance. This could lead to infections if used improperly.
Lack of Assurance of Sterility
Edge Pharma is recalling single-use IV syringes for phenylephrine HCl that may not be sterile. Using these syringes could lead to infections if they are contaminated.
The syringes lack assurance of sterility, meaning they might be contaminated with bacteria. If used for injections, this could lead to infections in the user.
Healthcare professionals and patients using these syringes for IV injections are at risk. Those who have received the recalled product may be affected.
Check for the product name 'Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection' from Edge Pharma. The NDC code 05446-1545-05 is also a key identifier.
Identify if your syringe matches the product name and NDC code 05446-1545-05.
The recall states there is a lack of assurance of sterility, so it is not safe to use without checking the recall status.
Look for the product name 'Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection' and NDC code 05446-1545-05.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0415-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0415-2022 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.
