Central Admixture Pharmacy Services recalls Cardioplegia Solution (Rx only) due to potential lack of sterility after FDA inspection. Products may not be sterile, risking infection during 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 recalls specific Cardioplegia Solution products because an FDA inspection raised concerns about their sterility. This could lead to infections during medical procedures if the solution is not properly sterile.
The FDA inspection found potential issues with sterility in the Cardioplegia Solution. This means the solution might not be sterile, which could cause infections during medical procedures if used improperly.
Healthcare professionals using this medication for cardiac surgery or related procedures. Patients receiving the solution through medical treatment are at risk if the solution is not sterile.
Check for the product name 'Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, 500 mL per bag'. Look for lot numbers 37-893848, 37-895681, 37-899250, or 37-901355 with expiration dates up to May 2023.
Identify the lot number and expiration date on the packaging to confirm if it matches the recalled batches.
The FDA inspection raised concerns about sterility, so the product may not be sterile. It is not safe for use without proper testing.
The recall record does not specify a replacement process or remedy.
The recall record does not provide specific instructions for disposal or return.
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-0654-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0654-2023 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.
