Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1.

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 # 37-896130, Exp 05/06/2023; 37-897957, Exp 05/13/2023; 37-899605, Exp 05/20/2023; 37-901357, Exp 05/27/2023

Distribution pattern: Nationwide in the USA.