FDA-Drug2013-06-12Class II
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, 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
9 Bags
Manufactured in
4 Creek Pkwy Ste A, N/A, Boothwyn, PA, United States
Products
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, 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-586-2013Don't want to check this manually?
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