Central Admixture Pharmacy Services recalls Cardioplegia Solution due to potential lack of sterility after FDA inspection. Products intended for sterile use may be contaminated.
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 raised concerns about sterility. This could mean the products are contaminated and unsafe for medical use.
The FDA inspection found potential lack of sterility in products meant to be sterile. Contaminated solutions could cause infections during medical procedures.
Healthcare professionals using these products for medical procedures are affected. Patients receiving the solution through these products are at risk of infection.
Check for lot numbers 37-894704, 37-896126, 37-898276, or 37-899141 with expiration dates up to May 2023. Products are sold under the brand name Cardioplegia Solution, Modified St Thomas Solution, low potassium, high sodium bicarbonate.
Look for lot numbers 37-894704, 37-896126, 37-898276, or 37-899141 on the packaging.
An FDA inspection raised concerns about the sterility of these products, which are intended to be sterile.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Yes, the products expire by April 30, 2023, or May 6, 2023, or May 14, 2023, or May 19, 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-0669-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0669-2023 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.
