FDA recall D-461-2015

Product

Abington Memorial Hospital (PA) TPN Neonatal Starter 0.6-0.99 Kg, Amino Acids, Neonate 5g, Dextrose 7.5%, 250 ml, Additives: heparin PF 125 unit(s)/ml, Calcium Gluconate 500mg, 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-461-2015