Central Admixture Pharmacy Services recalls neonatal TPN starter bags with amino acids and dextrose that lack sterility assurance due to insufficient decontamination validation. 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 may not be sterile. This could lead to infections in newborns receiving intravenous treatments.
The bags lack sufficient validation data for decontamination cycles, meaning they might not be sterile. If used for intravenous treatments in newborns, this could cause infections.
Healthcare providers administering neonatal intravenous treatments using this specific TPN starter bag are affected. Newborns receiving this medication are at risk of infection.
Check for the NDC number 72196-0421-1 and lot numbers 36-254913 (expiring 7/22/2023) or 36-256706 (expiring 7/30/2023). These bags are only available for prescription use.
Verify the NDC number and lot numbers listed in the recall notice to confirm if your bag is affected.
The recall states that the bags lack sufficient validation data for decontamination cycles, so they may not be sterile. Do not use these bags.
The recall does not specify a remedy, so contact the manufacturer for guidance on safe handling or disposal.
Check for the NDC number 72196-0421-1 and lot numbers 36-254913 (expiring 7/22/2023) or 36-256706 (expiring 7/30/2023).
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-1008-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1008-2023 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.
