FDA recall D-448-2015

Central Admixture Pharmacy Services, Inc. · Class I · drug

Product

Olathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, 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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-12-17
Report date: 2015-04-15
Termination date: 2015-08-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-448-2015