Edge Pharma recalls 1,500 mg/500 mL Vancomycin HCl injection due to lack of sterility assurance. Affected products were sold in the US starting August 2021. Consumers should contact the manufacturer 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 improperly. The recall affects certain batches sold in the US starting in August 2021.
The injection product lacks assurance of sterility, meaning it could be contaminated with bacteria. If used in medical procedures, this contamination could cause serious infections or other health issues.
Healthcare professionals and patients using the recalled vancomycin injection for IV treatment are affected. Those who have the specific batch numbers listed in the recall are at risk.
Check the product label for the NDC code 05446-1458-01. The product was sold in the US starting August 2021 and includes specific batch numbers.
Look for the NDC code 05446-1458-01 on the injection bag.
The recall states there is a lack of assurance of sterility, so it is not safe to use as it could cause infections.
The recall does not specify a remedy, so contact Edge Pharma directly for further instructions.
The product was first sold in the US starting August 2021.
We’ve drafted a message you can send Edge Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0426-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0426-2022 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.
