Central Admixture Pharmacy Services recalls neonatal TPN starter bags with potential contamination risk. These bags contain amino acids and dextrose with low calcium and heparin. The recall addresses lack of sterility assurance due to insufficient validation data for decontamination cycles.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services has recalled neonatal TPN starter bags that may not be sterile. This poses a risk of infection for newborns receiving intravenous fluids. The recall is due to insufficient validation data for decontamination cycles.
The bags lack sufficient validation data for decontamination cycles, meaning they may not be sterile. This could lead to infections in newborns if the fluids are contaminated. The hazard is specific to the manufacturing process and not a general issue with the product.
Newborns receiving intravenous nutrition through these specific TPN starter bags are at risk. Healthcare providers using the recalled bags for neonatal care are most affected.
Check for the product name: Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and heparin. Look for lot numbers 36-252367 (expiring 7/17/2023) or 36-256528 (expiring 7/29/2023).
Identify the lot number and expiration date on the bag to confirm if it is recalled.
The recall is due to lack of assurance of sterility. Validation data for decontamination cycles is insufficient, which could lead to contamination.
The official recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
Yes, check for lot numbers 36-252367 (expiring 7/17/2023) or 36-256528 (expiring 7/29/2023).
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-0980-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0980-2023 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.
