Central Admixture Pharmacy Services recalls Cardioplegia Solution (4:1 low potassium) due to potential contamination. Products may not be sterile, posing infection risks 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 is recalling Cardioplegia Solution (Reperfusate 4:1 low potassium) because an FDA inspection found possible contamination. This sterile medical product could cause infections if used in cardiac surgery.
The FDA inspection raised concerns about the sterility of the Cardioplegia Solution. If not properly sterile, the product could introduce harmful bacteria during cardiac surgery, leading to infections.
Healthcare professionals using this product for cardiac surgery. Patients undergoing heart procedures are at risk if the contaminated solution is used.
Check for lot numbers 37-893847, 37-895646, 37-897804, or 37-899236 with expiration dates up to May 2023. The product is a sterile medical solution for cardiac procedures.
Verify the lot number and expiration date on the packaging to confirm if it's in the recalled range.
The FDA inspection raised concerns about sterility, but the product is not yet confirmed unsafe. Use only products with lot numbers outside the recalled range.
The recall does not specify a remedy, so contact the manufacturer for guidance on safe handling or disposal.
Check the lot numbers 37-893847, 37-895646, 37-897804, or 37-899236 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-0653-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0653-2023 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.
