Neonatal TPN Starter Bag (Central Admixture) – Sterility Concern (2023)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0421-1.
Brand
Central Admixture Pharmacy Services, Inc.
Lot Codes / Batch Numbers
Lot # 37-893804, Exp 04/28/2023, 37-894713, Exp 04/30/2023, 37-896134, Exp 05/06/2023, 37-896497, Exp 05/07/2023, 37-897310, Exp 05/12/2023, 37-899623, Exp 05/20/2023
Products Sold
Lot # 37-893804, Exp 04/28/2023; 37-894713, Exp 04/30/2023; 37-896134, Exp 05/06/2023; 37-896497, Exp 05/07/2023; 37-897310, Exp 05/12/2023; 37-899623, Exp 05/20/2023
Central Admixture Pharmacy Services, Inc. is recalling Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, packa due to Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.. 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
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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 7, 2026