Central Admixture Pharmacy Services recalls sterile cardioplegia solution due to potential contamination concerns from FDA inspection. This product is used in heart surgeries and must be discarded if you have it.
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 recalls a specific cardioplegia solution used in heart surgeries because an FDA inspection raised concerns about its sterility. This means the product could be contaminated and unsafe for medical use.
The FDA inspection found that the product's sterility could not be assured. Cardioplegia solution is used during heart surgeries to protect the heart during procedures. If contaminated, it could cause serious infections or complications in patients.
Healthcare professionals who use this cardioplegia solution for heart surgeries are most at risk. Patients receiving this product during procedures may be affected if it's not sterile.
Check for the product name 'Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K' in 500 mL bags. It was sold by Central Admixture Pharmacy Services in Allentown, PA with NDC 71285-0011-1 and lot number 37-897075.
Discard the product immediately as it may be contaminated and unsafe for medical use.
No, the FDA inspection raised concerns about sterility, so this product is not safe for use.
Discard it immediately as it may be contaminated and unsafe for medical use.
Look for the product name 'Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K' in 500 mL bags with NDC 71285-0011-1 and lot number 37-897075.
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-0655-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0655-2023 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.