Central Admixture Pharmacy Services recalls neonatal TPN starter bags with low calcium and heparin due to lack of sterility assurance. These bags may not be sterile, posing risks to infants receiving IV treatments.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services has recalled neonatal TPN starter bags containing amino acids and dextrose with low calcium and heparin. The bags lack sufficient sterility assurance, which could lead to infections in infants receiving intravenous treatments.
The bags have insufficient validation data for decontamination cycles, meaning they may not be sterile. This lack of sterility could cause infections in infants receiving intravenous treatments.
Infants receiving intravenous nutrition through these specific TPN starter bags are at risk. Healthcare providers who administered the recalled bags may also be affected.
Check for the product name: Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with low calcium and heparin. Look for NDC: 72196-0428-1 and specific lot numbers listed in the recall notice.
Identify the product by checking the NDC number (72196-0428-1) and lot numbers (36-251195 to 36-254922) on the bag.
The recall is due to lack of assurance of sterility and insufficient validation data for decontamination cycles, which could lead to infections in infants.
The recall notice does not specify a remedy, so contact Central Admixture Pharmacy Services for guidance.
Yes, the recall includes lot numbers 36-251195, 36-252139, 36-252363, and 36-254922 with expiration dates up to July 22, 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-0998-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0998-2023 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.