Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, c...
FDA Recall #D-458-2015 — Class I — December 17, 2014
Product Description
Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine 5%, Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Reason for Recall
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Allentown, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
4 bags
Distribution
Nationwide
Code Information
lot numbers 37-74792 and 37-74635, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74792-0-2-R and CAPS Rx: 37-74635-0-2-R, Disp ID: 37-1124677 and Disp ID: 37-1124679
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated