drugs Class II Updated 2013-06-12

Pentec Health recalls Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral N

Recalled Product

Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 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: 04/24/13, 04/29/13 Discard after: 5/21/13, 05/22/13
View official government recall

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