Vital Care Compounder recalls phentolamine injections due to lack of sterility assurance. Products may be contaminated and should not be used. Check lot numbers for affected items.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Vital Care Compounder is recalling phentolamine injections because FDA inspections found the products could not be guaranteed sterile. Using these injections could lead to infections or other health risks.
FDA inspections found the products were produced without sufficient sterility assurance. This means the injections could contain harmful bacteria or other contaminants that could cause infections if used.
Prescription users of phentolamine injections. Patients with medical conditions requiring this medication are most at risk.
Check for lot numbers 60586 (BUD: 11/01/2022) or 64203 (BUD: 01/28/2023) on the vial. Products were sold by Vital Care Compounder in Hattiesburg, Mississippi.
Immediately discard any phentolamine injections with lot numbers 60586 or 64203.
FDA inspections found the products were produced without sufficient sterility assurance, meaning they could be contaminated.
Check the lot number on the vial; affected products have lot numbers 60586 (BUD: 11/01/2022) or 64203 (BUD: 01/28/2023).
Immediately discard the product and contact Vital Care Compounder for further instructions.
We’ve drafted a message you can send Vital Care Compounder to request your refund or repair — edit it as you like.
Subject: Recall D-0050-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0050-2023 from Vital Care Compounder. 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.
