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.
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 in vulnerable newborns.
The bags were not properly validated for sterility during decontamination cycles. This could allow bacteria to enter the solution, potentially causing infection in newborns.
Healthcare providers who use these bags for neonatal intravenous therapy. Newborns receiving this specific TPN solution are at risk of contamination.
Check for the NDC number 72196-0425-1 and lot number 36-254923 on the bag. These bags are only available through prescription and are used for neonatal intravenous therapy.
Verify the NDC number 72196-0425-1 and lot number 36-254923 on the bag.
The product is not safe for use as recalled due to lack of sterility validation. Healthcare providers should not use these bags.
Look for the NDC number 72196-0425-1 and lot number 36-254923 on the bag.
The recall does not specify a remedy, so contact your healthcare provider 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-0991-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0991-2023 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.
