Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0405-1.

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 # 37-893806, Exp 04/28/2023; 37-894701, Exp 04/30/2023; 37-895626, Exp 05/05/2023; 37-897277, Exp 05/12/2023; 37-899175, Exp 05/19/2023; 37-900971, Exp 05/26/2023

Distribution pattern: Nationwide in the USA.