drugs Class II Updated 2013-06-12

Pentec Health recalls Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition comp

Recalled Product

Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132

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: 4/25/13 Discard after: 5/16/13
View official government recall

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