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.

Recall Number: D-0698-2023

Firm: Central Admixture Pharmacy Services, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230531

Initiation Date: 20230428

Termination Date: 20250622

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

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.