Pharmacy Plus, Inc. dba Vital Care Compounder recalls ACETYLCYSTEINE OPTH 5% Solution droptainers due to potential contamination risks from inadequate sterility assurance during production.
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 ACETYLCYSTEINE OPTH 5% Solution droptainers because FDA inspections found they were produced without proper sterility assurance. This could lead to infections if used for eye treatments.
FDA inspections found the products were made without sufficient sterility assurance. This means the solution could be contaminated, potentially causing eye infections if used improperly.
Patients prescribed this medication by a healthcare provider who received the recalled droptainers. Those using the product for eye irrigation or treatment are at risk of infection.
Check for droptainers labeled 'ACETYLCYSTEINE OPTH 5% Solution, 15 mL' with lot numbers 66017 (BUD: 10/13/2022) or 66177 (BUD: 10/19/2022).
Identify the lot number and expiration date on the droptainer to confirm if it's in the recalled batch.
FDA inspections found the products were produced without sufficient sterility assurance, which could lead to contamination and eye infections.
Check for droptainers labeled 'ACETYLCYSTEINE OPTH 5% Solution, 15 mL' with lot numbers 66017 (BUD: 10/13/2022) or 66177 (BUD: 10/19/2022).
The recall record does not specify a remedy, so contact your healthcare provider for guidance on safe disposal or alternative options.
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-0027-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0027-2023 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.
