Central Admixture Pharmacy Services recalls neonatal TPN starter bags with low calcium and heparin due to lack of sterility assurance. Affected units have specific NDC and lot numbers. Contact for remedy details.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services is recalling neonatal TPN starter bags that contain low calcium and heparin. The bags lack proper sterility validation, which could lead to contamination risks for newborns receiving IV treatments.
The bags have insufficient validation for decontamination cycles, meaning they may not be sterile. This lack of sterility could introduce harmful bacteria into the baby's bloodstream during IV treatment, potentially causing serious infections.
Newborns receiving intravenous treatments through these specific neonatal TPN starter bags are at risk. Healthcare providers using the recalled bags for neonatal care are most affected.
Check for the NDC number 72196-0427-1 and lot numbers 36-252082 (expiring 7/16/2023) or 36-254925 (expiring 7/22/2023). These bags are only available for prescription use in neonatal care.
Verify the NDC number and lot numbers listed in the recall notice to confirm if your bag is affected.
The recall is due to lack of assurance of sterility in the bags, as validation data for decontamination cycles is missing.
The recall notice does not specify a remedy, so contact Central Admixture Pharmacy Services directly for guidance.
Yes, affected units have lot numbers 36-252082 (expiring 7/16/2023) or 36-254925 (expiring 7/22/2023).
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-1001-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1001-2023 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.