Advanced Compounding Solutions recalls Vancomycin HCl 1.5g in 500mL IV bags due to potential production space contamination. This affects prescription-only IV solutions manufactured on May 24, 2023, with expiration August 22, 2023.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Advanced Compounding Solutions is recalling Vancomycin HCl 1.5g IV bags that were made on May 24, 2023. The recall is because production areas might have been contaminated during manufacturing, which could affect the safety of the medication.
The recall is due to potential contamination of production areas during manufacturing. This could mean the medication might not be safe for use, though the exact risk level isn't specified in the notice.
Healthcare professionals who have prescription-only Vancomycin HCl 1.5g IV bags with lot number 20230524-0113AB. Patients receiving this medication through IV administration are at risk if they use contaminated products.
Check for the lot number 20230524-0113AB on the IV bag label. The product is a prescription-only Vancomycin HCl 1.5g solution in 500mL of 0.9% Sodium Chloride, with an expiration date of August 22, 2023.
Look for the lot number 20230524-0113AB on the IV bag label to confirm if it's affected.
The recall notice states there may have been production space contamination, but it does not specify if the product is unsafe. The manufacturer has not provided details on the exact risk.
Check the lot number on the IV bag label. The recalled product has lot number 20230524-0113AB and expires August 22, 2023.
The recall notice does not specify a remedy, so the manufacturer has not provided instructions on what to do with the product.
We’ve drafted a message you can send Advanced Compounding Solutions to request your refund or repair — edit it as you like.
Subject: Recall D-0929-2023 — Advanced Compounding Solutions Advanced Compounding Solutions Hello, I own a Advanced Compounding Solutions that is covered by recall D-0929-2023 from Advanced Compounding Solutions. 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.