drugs Class II Updated 2013-06-12

Pentec Health recalls Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nut

Recalled Product

Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL 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: a) 04/26/13, b) 04/30/13 Discard after: a) and b) 5/21/13
View official government recall

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