Central Admixture Pharmacy Services recalls Cardioplegia Solution (NDC 71285-0104-1) due to potential contamination 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 is recalling Cardioplegia Solution for possible contamination. This sterile medical product could cause infections if used in procedures due to lack of sterility assurance.
The FDA inspection found the products may not be sterile. Cardioplegia solution is used during heart surgery to protect the heart during procedures. Contamination could lead to infections in patients.
Healthcare professionals using this cardioplegia solution for cardiac surgery. Patients receiving the solution during procedures are at risk of infection.
Check for NDC 71285-0104-1, 1000 mL bags, with lot numbers 37-893850 to 37-900616. Products expire by April 2023 to May 2023.
Verify the NDC code 71285-0104-1 and lot numbers listed in the recall notice.
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.
Look for NDC 71285-0104-1, 1000 mL bags with lot numbers 37-893850 to 37-900616.
The recall does not specify a remedy, so contact the manufacturer for guidance.
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-0662-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0662-2023 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.