Central Admixture Pharmacy Services recalls neonatal TPN starter bags with amino acids and dextrose that may not be sterile, risking infection in infants. Affected units have specific lot numbers and expiration dates.
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, which could lead to infections in infants receiving intravenous fluids. This recall affects specific lot numbers and expiration dates.
The recall states that the bags lack assurance of sterility due to insufficient validation data for decontamination cycles. This means the bags could become contaminated, potentially causing infections in infants receiving intravenous fluids.
Healthcare providers administering neonatal intravenous nutrition to infants are most at risk. The affected products are used in hospitals and clinics for specific medical treatments.
Check for the product name: Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with Heparin, IV Bag, 250mL. Look for lot numbers 36-251452 or 36-254918 with expiration dates of July 14, 2023 or July 22, 2023.
Identify the lot number and expiration date on the bag to determine if it is affected.
The recall is due to a lack of assurance of sterility in the bags, as validation data for decontamination cycles is insufficient.
The official recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
Yes, lot numbers 36-251452 and 36-254918 with expiration dates of July 14, 2023 and July 22, 2023 are affected.
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-1009-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1009-2023 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.
