Edge Pharma recalls Vancomycin HCl Oral Solution (PF) 125mg/2.5mL due to CGMP deviations. Affected units have specific NDC and batch numbers. Consumers should contact Edge Pharma for details.
CGMP Deviations
Edge Pharma is recalling a specific Vancomycin HCl Oral Solution product due to manufacturing quality control issues. This recall affects patients using the medication as it may not meet safety standards.
The recall is for CGMP (Current Good Manufacturing Practice) deviations, which means the product was made without following proper quality control standards. This could lead to the medication not being safe or effective for patients.
Patients using the recalled Vancomycin HCl Oral Solution (PF) 125mg/2.5mL may be affected. Those with the specific NDC number 05446-1348-01 are most at risk.
Check for the NDC number 05446-1348-01 on the product label. The product was sold between September 2021 and January 2022 with specific batch numbers.
Reach out to Edge Pharma, LLC at 856 Hercules Dr., Colchester, VT 05446 for specific recall details and instructions.
The recall indicates potential manufacturing quality control issues, so the product may not be safe. Contact Edge Pharma for confirmation.
Contact Edge Pharma, LLC directly for instructions on what to do with the recalled product.
Look for the NDC number 05446-1348-01 on the product label. The product was sold between September 2021 and January 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-0448-2022 — Edge Pharma Edge Pharma Hello, I own a Edge Pharma that is covered by recall D-0448-2022 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.
