Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.

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 # 37-894695, Exp 04/30/2023; 37-895693, Exp 05/05/2023; 37-900065, Exp 05/21/2023; 37-900622, Exp 05/25/2023

Distribution pattern: Nationwide in the USA.