drugs Class II Updated 2013-06-12

Pentec Health recalls Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - di

Recalled Product

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

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 Discard after: 05/15/13
View official government recall

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