Central Admixture Pharmacy Services, Inc. — Class II Recall

Product

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/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 71285-0422-1.

Reason

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

Classification

Class II

Status

Terminated

Lot

Lot # 37-893819, Exp 04/28/2023; 37-894702, 37-894710, Exp 04/30/2023; 37-895215, Exp 05/04/2023; 37-897282, Exp 05/12/2023; 37-897921, Exp 05/13/2023; 37-898309, Exp 05/14/2023; 37-899199, Exp 05/19/2023; 37-900058, Exp 05/21/2023

Date

2023-05-31

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.