Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additiv...
FDA Recall #D-453-2015 — Class I — December 17, 2014
Product Description
Providence Hospital Southfield (MI) Neonate TPN Starter Bag, Trophamine 3g, Dextrose 10%, Additives: heparin PF 0.5 unit(s)/mL, Calcium Gluconate 600mg, 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
6 bags
Distribution
Nationwide
Code Information
lot number 37-74680, Made on 15 DEC 2014, EXP 24 DEC 2014,CAPS Rx: 37-74680-0-6-R, Disp ID: 37-1124687
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated