FDA-Drug2013-06-12Class II
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
Pentec Health
Hazard
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Sold states
Dialysis Centers Direct to patient
Affected count
3 units
Manufactured in
4 Creek Pkwy Ste A, N/A, Boothwyn, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-582-2013Don't want to check this manually?
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