PlainRecalls
FDA Drug Critical Class I Terminated

Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, 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.

Reported: April 15, 2015 Initiated: December 17, 2014 #D-446-2015

Product Description

Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, 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.

Details

Units Affected
4 bags
Distribution
Nationwide
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
Advocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, 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.. Recalled by Central Admixture Pharmacy Services, Inc.. Units affected: 4 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-446-2015.