Central Admixture Pharmacy Services recalls neonatal TPN starter bags due to lack of sterility assurance from sanitization cycles. This affects specific IV bags used in hospitals for newborns.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services recalls neonatal TPN starter bags that may not be sterile after sanitization. This poses a risk of infection for newborns receiving intravenous fluids.
The bags lack validated sanitization cycles, meaning they might not be sterile after cleaning. This could lead to infections if used in newborns' intravenous treatments.
Healthcare providers using these IV bags for newborns in hospitals are most at risk. The product is prescription-only and used in neonatal care settings.
Check for the product name: Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN. Look for NDC 72196-0422-1 and lot number 36-260017.
Identify the product by checking the NDC number 72196-0422-1 and lot number 36-260017 on the bag.
The recall states there is a lack of assurance of sterility, so it is not safe for use in newborns.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
Look for the NDC number 72196-0422-1 and lot number 36-260017 on the bag.
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-1122-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1122-2023 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.
