Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Add...
FDA Recall #D-457-2015 — Class I — December 17, 2014
Product Description
Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, compound vol: 150 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
10 bags
Distribution
Nationwide
Code Information
lot number 37-74503, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74503-0-10-R, Disp ID: 37-1124660
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated