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 because an FDA inspection raised concerns about the sterility of the products. This could lead to infections if the solution is used in medical procedures.
The FDA inspection found that the solution may not be sterile. If the solution is not sterile, it could cause infections in patients during medical procedures.
Healthcare professionals who use this cardioplegia solution for medical procedures are affected. Patients receiving the solution during surgery are at risk of infection.
Check for the product name 'Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K' in 522.8 mL bags. Look for lot numbers 37-894326 through 37-899267 with expiration dates up to May 19, 2023.
Identify the product by checking the lot number and expiration date on the packaging.
The FDA inspection raised concerns about sterility, so the product is not safe for use in medical procedures.
Check for the product name 'Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K' in 522.8 mL bags with lot numbers 37-894326 through 37-899267.
The recall does not specify a remedy, so contact the manufacturer for guidance.
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-0672-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0672-2023 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.
