Edge Pharma recalls neostigmine methylsulfate syringes due to lack of sterility assurance. This could lead to infections if used improperly. Affected products were sold from 2021 to 2022.
Lack of Assurance of Sterility
Edge Pharma recalled neostigmine methylsulfate syringes because they may not be sterile. Using these syringes could cause 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 or other health issues.
Healthcare professionals and patients who use neostigmine methylsulfate for IV or IM injections may be affected. Those with medical conditions requiring this medication are at higher risk.
Check for the product name 'Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection' from Edge Pharma. The NDC code 05446-1549-05 and the date range 2021 to 2022 indicate the affected products.
Look for the NDC code 05446-1549-05 on the syringe label to confirm if it is affected.
The recall is due to a lack of assurance of sterility, which could lead to infections if the syringes are contaminated.
The official notice does not specify a remedy, so contact Edge Pharma directly for guidance.
The affected products were sold from 2021 to 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-0411-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0411-2022 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.
