Edge Pharma recalls 1,250 mg/250 mL Vancomycin HCl IV injection due to lack of sterility assurance. Affected units were sold from December 2021 to January 2022. Consumers should contact Edge Pharma for details.
Lack of Assurance of Sterility
Edge Pharma is recalling a specific vancomycin injection product because it may not be sterile. This could lead to infections if used in medical settings. The recall affects certain batches sold between December 2021 and January 2022.
The product lacks assurance of sterility, meaning it might contain harmful bacteria or other contaminants. If used in medical procedures, this could cause serious infections or other health issues.
Healthcare professionals using the injection for medical treatments are most at risk. Patients receiving this medication through IV infusion may also be affected.
Check for the product name 'Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free)'. The NDC code 05446-1456-01 identifies the affected units sold between December 2021 and January 2022.
Look for the NDC code 05446-1456-01 on the packaging to confirm if the product is affected.
The recall states there is a lack of assurance of sterility, so it is not safe to use as it could cause infections.
Contact Edge Pharma at 856 Hercules Dr., Colchester, VT 05446 or check their official recall notice online.
The recall does not specify a remedy, so contact Edge Pharma directly for guidance on next steps.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0425-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0425-2022 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.
