Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and H...
FDA Recall #D-1120-2023 — Class II — August 17, 2023
Product Description
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
132 bags
Distribution
Nationwide in the USA
Code Information
Lot# 36-260018, Exp 8/19/2023, 36-262155, Exp 8/21/2023 ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated