drugs Class II Updated 2013-06-12

Pentec Health recalls Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral

Recalled Product

Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. 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: Date: 04/30/13 Discard After: 05/21/13
View official government recall

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