Vital Care Compounder recalls 2% VORICONAZOLE OPTH SOLUTION 10ml droptainer due to lack of sterility assurance from FDA inspection. This medication is for prescription use only.
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 has recalled 2% VORICONAZOLE OPTH SOLUTION 10ml droptainer products because FDA found they were not produced with enough sterility assurance. Using these products could lead to infections since they are meant to be sterile.
FDA inspections found the product was made without proper sterility assurance. This means the solution might not be sterile, which could cause eye infections if used. The product is for prescription use only and must be handled carefully.
Prescription users of this eye drop solution who purchased it from pharmacies or online. People with compromised immune systems are at higher risk of infection.
Check the product label for 'VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer'. Look for lot number 66757 with a batch date of 10/14/2022.
Look for the lot number 66757 and batch date 10/14/2022 on the product label.
No, the FDA found the product was not produced with enough sterility assurance, so it could cause infections if used.
Check the product label for 'VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer' with lot number 66757 and batch date 10/14/2022.
The recall record does not specify a remedy, so contact your pharmacy or healthcare provider for guidance.
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-0057-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0057-2023 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.
