Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextr...
FDA Recall #D-462-2015 — Class I — December 17, 2014
Product Description
Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, 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
1 bag
Distribution
Nationwide
Code Information
lot number 37-74653, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74653-0-1-R, Disp ID: 37-1124735
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated