Central Admixture Pharmacy Services recalls neonatal TPN starter bags due to potential contamination. Products may not be sterile, posing risks to infants receiving treatment. Affected lots expire by May 2023.
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 TPN starter bags that contain amino acids and dextrose. The bags were found to have potential sterility issues after an FDA inspection, which could lead to infections in infants receiving these treatments.
The FDA inspection raised concerns about the sterility of the bags. If the bags are not sterile, they could introduce harmful bacteria into an infant's bloodstream, causing serious infections.
Infants receiving neonatal TPN (total parenteral nutrition) treatments through these bags are at risk. Healthcare providers using the product for medical purposes may be affected.
Check for the product name 'Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%' in 250 mL bags. Look for lot numbers 37-895214, 37-897950, or 37-899603 with expiration dates by May 2023.
Identify the lot number and expiration date on the bag to determine if it is affected.
The FDA inspection raised concerns about the sterility of the product, which could lead to infections in infants receiving treatment.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Yes, affected lots are 37-895214, 37-897950, and 37-899603 with expiration dates by 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-0682-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-0682-2023 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.
