Central Admixture Pharmacy Services recalls specific lots of Cardioplegia Solution due to potential contamination. This sterile medical product may not meet sterility standards after FDA inspection. Patients and healthcare providers should contact the manufacturer for details.
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 certain lots of Cardioplegia Solution (low potassium) because an FDA inspection raised concerns about the product's sterility. This is serious because the solution is meant to be sterile for medical use, and contamination could cause infections or other complications.
The FDA inspection found that the solution may not be sterile as intended. Cardioplegia solution is used during heart surgeries to protect the heart tissue, so contamination could lead to infections or other complications in patients.
Healthcare providers and patients using this specific cardioplegia solution for medical procedures are affected. Those with the recalled lots are at risk of infection if the solution is used improperly.
Check the product label for the lot numbers: 37-894320, 37-894324, 37-897297, or 37-898509. These lots were manufactured between 2023 and 2024 and expire by April 2023 or May 2023.
Look for the lot numbers 37-894320, 37-894324, 37-897297, or 37-898509 on the packaging.
The FDA inspection raised concerns about sterility, so the product may not be safe for medical use. Do not use the recalled lots.
Contact Central Admixture Pharmacy Services at 6580 Snowdrift Road, Allentown, PA 18106 for instructions on what to do with the product.
Check the product label for the lot numbers: 37-894320, 37-894324, 37-897297, or 37-898509.
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-0674-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0674-2023 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.