drugs Class II Updated 2013-06-12

Pentec Health recalls Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - di

Recalled Product

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL 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: 04/23/13, 04/24/13, 04/29/13, 05/01/13 Discard after: 05/20/13, 05/22/13
View official government recall

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