TPN Neonatal Starter Bag (Central Admixture) - non-sterile risk (2014)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin PF 62.5 units, Calcium Gluconate 500mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Brand
Central Admixture Pharmacy Services, Inc.
Lot Codes / Batch Numbers
lot number 37-74671, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74671-0-6-R, Disp ID: 37-1124546
Products Sold
lot number 37-74671, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74671-0-6-R, Disp ID: 37-1124546
Central Admixture Pharmacy Services, Inc. is recalling Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10%, Additives: heparin P due to Non-Sterility: Out of specification results for the sterility test for microbial contamination.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 12, 2026