Pentec Health recalls Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL b
Recalled June 12, 2013 · FDA recall D-581-2013 · Pentec Health
Hazard
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. · FDA Class II
Units
1 Bag
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 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
Manufacturer(s)
Pentec Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →