Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Recall Number: D-590-2013

Firm: Pentec Health

Classification: Class II

Status: Terminated

Report Date: 20130612

Initiation Date: 20130515

Termination Date: 20141216

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

Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132