Central Admixture Pharmacy Services recalls neonatal PN starter bags with potential sterility issues. Products may not be sterile, posing infection risks for newborns. Contact for details.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Central Admixture Pharmacy Services is recalling neonatal PN starter bags that may not be sterile, which could lead to infections in newborns. This recall follows an FDA inspection that raised concerns about sterility.
The products were found to lack assurance of sterility during an FDA inspection. This means the bags could contain contaminants that cause infections in newborns who receive the medication through IV.
Newborns receiving this medication through IV infusion are at risk. Healthcare providers using these products for neonatal care are most affected.
Check for the product name: Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN. Look for lot numbers 37-894695, 37-895693, 37-900065, or 37-900622 with expiration dates up to May 2023.
Identify the lot number and expiration date on the bag to confirm if it's in the recalled range.
The FDA inspection found concerns about the sterility of these products, which could lead to infections in newborns.
The recall does not specify a remedy, so contact Central Admixture Pharmacy Services for guidance.
Yes, avoid lot numbers 37-894695, 37-895693, 37-900065, and 37-900622 with expiration dates up to May 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-0698-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0698-2023 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.
