Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additive...
FDA Recall #D-449-2015 — Class I — December 17, 2014
Product Description
Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, 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
10 bags
Distribution
Nationwide
Code Information
lot number 37-74779, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74779-0-10-R, Disp ID: 37-1124608
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated