Central Admixture Pharmacy Services recalls high potassium cardioplegia solution due to potential sterility issues found during FDA inspection. Products may not be sterile and could cause infections if used in medical procedures.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services is recalling high-potassium cardioplegia solution for possible sterility issues. This product is used in medical procedures and could cause infections if not properly sterile.
FDA inspections found potential sterility problems with the product. If the solution is not sterile, it could cause infections during medical procedures, especially in critical care settings.
Healthcare professionals using this product for medical procedures. Patients receiving this solution during surgery or critical care are at risk of infection.
Check for the product name 'Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K' in 542 mL bags. Look for lot numbers 37-895217, 37-898803, or 37-900614 with expiration dates up to May 2023.
Identify the product by checking the lot number and expiration date on the packaging.
The FDA found potential sterility issues, so the product may not be sterile and could cause infections. Do not use until the recall is resolved.
Check the product details to see if it is in the recalled lot numbers. If it is, stop using it and contact the manufacturer for instructions.
The recall record does not specify a replacement process. Contact Central Admixture Pharmacy Services for assistance.
We’ve drafted a message you can send Central Admixture Pharmacy Services to request your refund or repair — edit it as you like.
Subject: Recall D-0676-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0676-2023 from Central Admixture Pharmacy Services. 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.