Central Admixture Pharmacy Services recalls Cardioplegia Solution (500mL bags) due to potential contamination. Products may not be sterile, posing risks during medical procedures. Check NDC 71285-0111-1 and lot numbers for affected items.
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 (500mL bags) because an FDA inspection raised concerns about the products' sterility. This could lead to infections during medical procedures if the solution is not properly sterile.
The solution is intended to be sterile but an FDA inspection found potential contamination. If not properly sterile, it could cause infections or other complications during medical procedures.
Healthcare professionals using this product for medical procedures are most at risk. Patients receiving the solution during surgery or critical care may be affected if the product is contaminated.
Check for NDC 71285-0111-1 and lot numbers: 37-894299 (exp 04/29/2023), 37-897051 (exp 05/11/2023), 37-897368 (exp 05/12/2023), 37-898794 (exp 05/18/2023), 37-899614 (exp 05/20/2023), 37-900608 (exp 05/25/2023).
Identify the NDC 71285-0111-1 and lot numbers listed above to confirm if your product is affected.
The FDA inspection raised concerns about sterility, so the product may not be safe for use. Do not use affected products until the recall is resolved.
Check the NDC and lot numbers to see if your product is affected. If it is, stop using it and contact the manufacturer for instructions.
The recall record does not specify replacement options. Contact Central Admixture Pharmacy Services for assistance.
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-0666-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0666-2023 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.