Central Admixture Pharmacy Services recalls Cardioplegia Solution (Induction 4:1, HIGH POTASSIUM/low tromethamine) due to lack of sterility assurance after FDA inspection. Products sold in 500mL bags with specific lot numbers and expiration dates.
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 has recalled Cardioplegia Solution (Induction 4:1) because an FDA inspection raised concerns about the sterility of these products. This is a serious issue as the solution is intended to be sterile but may contain contaminants that could cause infections.
The FDA inspection found that the sterility of the Cardioplegia Solution could not be assured. This means the solution might contain harmful bacteria or other contaminants that could cause serious infections in patients during cardiac surgery.
Healthcare professionals who use this medication for cardiac surgery are most at risk. Patients receiving this solution through a hospital pharmacy may also be affected.
Check for the product name 'Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K' in 500mL bags. Look for lot numbers 37-895647, 37-898310, 37-899622, or 37-900951 with expiration dates up to May 2023.
Verify the product name, lot number, and expiration date to confirm if it is recalled.
The FDA inspection raised concerns about sterility, so the product is not safe to use as it may contain harmful contaminants.
The recall does not specify a remedy, so contact the manufacturer directly for guidance.
Check for lot numbers 37-895647, 37-898310, 37-899622, or 37-900951 with expiration dates up to May 2023.
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-0659-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0659-2023 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.
