Pentec Health recalls Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a)
Recalled June 12, 2013 · FDA recall D-594-2013 · Pentec Health
Hazard
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. · FDA Class II
Units
8 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
Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL 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 →