Northern VA Compounders recalls QuadMix Standard 001 injectable due to lack of sterility assurance. This compounded medication, sold in 2.5mL vials, may cause infections if used.
Lack of Assurance of Sterility
Northern VA Compounders is recalling QuadMix Standard 001 injectable medication because it lacks sterility assurance. Using this product could lead to infections, especially since it's compounded for medical use.
The medication was compounded without adequate sterility testing, meaning it could contain harmful bacteria or other contaminants. This poses a risk of infection if the product is injected into the body.
Patients prescribed this compounded medication by healthcare providers in the Northern VA region. Those using the product without proper sterility checks are at risk of infection.
Look for QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL in 2.5mL vials. The lot numbers 11162022@10 (expiring Dec 31, 2022) and 12052022@9 (expiring Jan 19, 2023) are affected.
Identify the lot number and expiration date on the vial to determine if it's part of the recalled batch.
The official recall states the product lacks sterility assurance, so it is not safe to use as it could cause infections.
Look for QuadMix Standard 001 in 2.5mL vials with lot numbers 11162022@10 (expiring Dec 31, 2022) or 12052022@9 (expiring Jan 19, 2023).
The recall does not specify a remedy, so contact your healthcare provider for guidance on safe disposal or alternatives.
We’ve drafted a message you can send Northern VA Compounders to request your refund or repair — edit it as you like.
Subject: Recall D-0107-2023 — Northern VA Compounders Northern VA Compounders Hello, I own a Northern VA Compounders that is covered by recall D-0107-2023 from Northern VA Compounders. 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.
