drugs Class II Updated 2013-06-12

Pentec Health recalls Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition -

Recalled Product

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Hazard / Issue

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

Issued by

FDA

Distribution: Dialysis Centers Direct to patient
Lot/Code Info: Compounding Date: 04/24/13 Discard after: 5/15/13
View official government recall

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