FDA recall D-457-2015

Product

Hackensack University Med Ctr (NJ) 5% Dextrose Neonatal Solution, Trophamine 3%, Dextrose 5%, Additives: Calcium Gluconate 0.46mEq/mL, 7mEq/L, 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.

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-457-2015