Central Admixture Pharmacy Services recalls Cardioplegia Solution (830mL bags) due to potential contamination. Products may not be sterile, risking infections during medical procedures. Affected lots expire by April 2023.
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 Cardioplegia Solution products because an FDA inspection found possible contamination. This could lead to infections during surgeries or medical procedures if the solution isn't sterile.
The FDA inspection raised concerns about the sterility of these products. If the solution isn't sterile, it could cause infections during medical procedures, especially in critical surgeries.
Healthcare facilities using this product for cardiac surgery or medical procedures. Patients undergoing surgeries with this solution are at risk of infection.
Check for the product name 'Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K' in 830mL bags. Look for lot numbers 37-894304 through 37-900461 with expiration dates up to May 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 may not be safe for medical use. Do not use until the recall is resolved.
Contact Central Admixture Pharmacy Services for instructions on how to handle the recalled product.
Check the lot number on the packaging; affected lots are 37-894304 through 37-900461 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-0658-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0658-2023 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.