Central Admixture Pharmacy Services recalls neonatal TPN starter bags with potential lack of sterility due to unvalidated sanitization cycles. Affected units have specific NDC and lot numbers. Contact for remedy details.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services is recalling neonatal TPN starter bags that may not be sterile because their sanitization cycles weren't properly validated. This could lead to infections in newborns receiving the treatment.
The bags may not be sterile because the sanitization cycles used to clean them weren't validated. If the bags become contaminated, newborns receiving the treatment could get infections.
Newborns receiving neonatal TPN treatment through this specific bag type are at risk. Healthcare providers using these bags for intravenous feeding in hospitals are most affected.
Check for the NDC number 72196-0418-1 and lot number 36-260015 on the bag. These bags are only sold with a prescription and are used in hospitals for neonatal intravenous feeding.
Look for NDC 72196-0418-1 and lot number 36-260015 on the bag.
The recall states there is a lack of assurance of sterility due to unvalidated sanitization cycles, so it is not safe to use.
The recall record does not specify a remedy or replacement process.
The expiration date is August 19, 2023, as indicated on the lot number.
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-1114-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1114-2023 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.
