Pentec Health recalls Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b)
Recalled June 12, 2013 · FDA recall D-586-2013 · Pentec Health
Hazard
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. · FDA Class II
Units
9 Bags
Sold at
Dialysis Centers Direct to patient
Description
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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
Manufacturer(s)
Pentec Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →