Vitae Enim Vitae Scientific recalls PAPAVERINE HYDROCHLORIDE Injection vials due to lack of sterility assurance. Products may be contaminated and unsafe for medical use.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Vitae Enim Vitae Scientific has recalled certain PAPAVERINE HYDROCHLORIDE Injection vials because they may not be sterile. Using these vials could lead to infections or other health risks if the product is contaminated.
The injection vials were manufactured without proper sterility assurance, which could lead to contamination. This poses a risk of infection or other health issues if the product is used without being sterile.
Patients prescribed PAPAVERINE HYDROCHLORIDE Injection by healthcare providers. Those using the recalled vials for medical treatment are at risk of infection if the product is contaminated.
Check for vials labeled 'PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL)' in boxes with 25 or 10 single-use vials. Lot numbers include 20VPHI037-039 (expiring 12/31/2022) or 21VPHI021-023 (expiring 6/30/2023).
Identify the vial packaging and lot numbers to confirm if your product is recalled.
Inform your doctor or pharmacist about the recalled product to discuss next steps.
The product may not be sterile due to deviations from Current Good Manufacturing Practices, which could lead to contamination and infection risks.
Check the product details and contact your healthcare provider for guidance on next steps.
Yes, avoid vials with lot numbers 20VPHI037-039 (expiring 12/31/2022) or 21VPHI021-023 (expiring 6/30/2023).
We’ve drafted a message you can send Vitae Enim Vitae Scientific to request your refund or repair — edit it as you like.
Subject: Recall D-0742-2022 — Vitae Enim Vitae Scientific Vitae Enim Vitae Scientific Hello, I own a Vitae Enim Vitae Scientific that is covered by recall D-0742-2022 from Vitae Enim Vitae Scientific. 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.
