Pharmacy Plus, Inc. dba Vital Care Compounder recalls MITOMYCIN injection products due to lack of sterility assurance. Products may contain harmful bacteria.
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 MITOMYCIN injection products because FDA inspections found they were not produced with enough sterility assurance. This could lead to infections if used improperly.
FDA inspections found the products were made without sufficient sterility assurance. This means the injections could contain harmful bacteria, which might cause serious infections if used in medical procedures.
Patients prescribed MITOMYCIN injections by doctors who received these specific products are affected. Healthcare providers using these products for medical treatments are at higher risk.
Check for product labels with 'MITOMYCIN INJECTION 0.375 mg/mL SYR' and lot numbers 60618 (BUD: 5/6/2023) or 66536 (BUD: 7/8/2023).
Look for lot numbers 60618 (BUD: 5/6/2023) or 66536 (BUD: 7/8/2023) on the product.
FDA inspections found the products were produced without sufficient sterility assurance, which could lead to contamination.
The official recall notice does not specify a remedy or action steps for consumers.
Yes, check for lot numbers 60618 (BUD: 5/6/2023) or 66536 (BUD: 7/8/2023).
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-0039-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0039-2023 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.
