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.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Code information: 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

Distribution pattern: Nationwide in the USA.