Pentec Health recalls Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and
Recalled June 12, 2013 · FDA recall D-589-2013 · Pentec Health
Hazard
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions · FDA Class II
Units
38 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 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, 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 →