Edge Pharma recalls Vitamin K Oral Solution (5 mg/mL) due to CGMP deviations. This may affect safety but no specific harm is confirmed. Check your product's NDC 05446-1132-03 for details.
CGMP Deviations
Edge Pharma is recalling Vitamin K Oral Solution (5 mg/mL) because of manufacturing quality control issues. This recall does not specify a risk of injury or harm to users.
CGMP deviations refer to manufacturing quality control failures. This could mean the product is not safe or effective, but the recall does not specify how this affects users.
People who own or use this Vitamin K Oral Solution (NDC 05446-1132-03) are affected. Those with medical conditions requiring Vitamin K supplements may be at higher risk.
Check for the product name 'Vitamin K Oral Solution (PF)', 5 mg/mL, 1mL per syringe, NDC 05446-1132-03. It was sold between October 27, 2021, and November 16, 2021.
Look for the NDC code 05446-1132-03 on the label to confirm if your product is affected.
The recall mentions CGMP deviations but does not specify any risk of injury or harm to users.
Check for the NDC code 05446-1132-03 on the label. The product was sold between October 27, 2021, and November 16, 2021.
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-0445-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0445-2022 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.
