PlainRecalls
FDA Drug Critical Class I Terminated

Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 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.

Reported: April 15, 2015 Initiated: December 17, 2014 #D-438-2015

Product Description

Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 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.

Details

Units Affected
10 bags
Distribution
Nationwide
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 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.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 10 bags.
Why was this product recalled?
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 15, 2015. Severity: Critical. Recall number: D-438-2015.