Vital Care Compounder recalls Prostaglandin E1 injection vials due to potential contamination from lack of sterility assurance during manufacturing. This affects specific lots produced in 2022.
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 Prostaglandin E1 injection vials that may not be sterile. Using these vials could lead to infections or other health risks if injected.
FDA inspections found the vials were produced without proper sterility assurance. This means the products could contain harmful bacteria or other contaminants that might cause infections if injected.
Patients prescribed Prostaglandin E1 injections for medical use. Healthcare providers who dispense these injections may also be affected.
Check for vials labeled 'Prostaglandin E1 Injection Solution 500mcg/ml, 1 ml vials, Rx only'. Look for lot numbers 59993 (bought by 10/18/2022) or 60932 (bought by 11/09/2022).
Identify the lot number on the vial label to determine if it's 59993 or 60932.
If the vial has a lot number of 59993 or 60932, discard it immediately and contact your healthcare provider.
FDA inspections found the vials were produced without proper sterility assurance, which could lead to contamination.
If your vial has lot numbers 59993 or 60932, discard it immediately and contact your healthcare provider.
No, these specific vials may not be sterile and could cause infections if injected.
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-0052-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0052-2023 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.
