Central Admixture Pharmacy Services recalls Cardioplegia Solution (IV bag) due to lack of sterility assurance. This product is for medical use only and may cause infections if not sterile.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (15 mEq K, Reperfusate 4:1, IV bag) because it lacks proper sterility assurance. This could lead to infections if the solution is not sterile during medical use.
The solution may not be sterile due to insufficient validation data for decontamination cycles. This lack of sterility could lead to infections if the product is used in medical procedures.
Healthcare professionals using this product for medical procedures are affected. Patients receiving this solution through IV administration are at risk of infection.
Check for the product name 'Cardioplegia Solution', 15 mEq K, Reperfusate 4:1, IV bag, total volume 477.5mL. The NDC number is 72196-0008-1 and lot number 36-252142.
Verify the NDC number 72196-0008-1 and lot number 36-252142 on the product label.
The recall states there is a lack of sterility assurance, so it is not safe for medical use. The product should not be used until the recall is resolved.
The expiration date is July 16, 2023, as indicated on the product label.
The recall record does not specify a replacement process or remedy.
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-1022-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1022-2023 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.