Pharmacy Plus, Inc. dba Vital Care Compounder recalls LAURETH-9 INJ 2% Solution vials due to lack of sterility assurance. FDA inspection found production did not guarantee sterile products.
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 LAURETH-9 INJ 2% Solution vials because FDA found they were not produced with sterility assurance. This could lead to infections if used improperly.
FDA inspection found the vials were produced without proper sterility assurance. This means the solution could be contaminated, leading to infections if injected or used medically.
Prescription patients using LAURETH-9 INJ 2% Solution vials from Vital Care Compounder. Healthcare providers handling the product are at higher risk due to potential contamination.
Check for vials labeled 'LAURETH-9 INJ 2% Solution, 30 ML' from Vital Care Compounder. Lot number 66513 with a batch date of November 10, 2022.
Look for the lot number 66513 and batch date of November 10, 2022 on the vial label.
The FDA found the product was not produced with sterility assurance, so it may be contaminated. Do not use the recalled vials.
Check for vials labeled 'LAURETH-9 INJ 2% Solution, 30 ML' with lot number 66513 and batch date November 10, 2022.
The recall does not specify a remedy, so contact Vital Care Compounder directly 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-0034-2023 — Vital Care Compounder Vital Care Compounder Hello, I own a Vital Care Compounder that is covered by recall D-0034-2023 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.
