FDA recall D-586-2013

Product

Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Reason for recall

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Distribution

Dialysis Centers Direct to patient

Key facts

Status

Terminated

Initiation date

2013-05-15

Report date

2013-06-12

Termination date

2014-12-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boothwyn, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-586-2013