Home / Recalls / Pentec Health / D-586-2013

D-586-2013 Class II Terminated

Recalled by Pentec Health — Boothwyn, PA

Recall Details

Product Type
Drugs
Report Date
June 12, 2013
Initiation Date
May 15, 2013
Termination Date
December 16, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 Bags

Product Description

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

Reason for Recall

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Distribution Pattern

Dialysis Centers Direct to patient

Code Information

Compounding Date: 04/24/13 Discard after: 05/15/13

Other recalls by Pentec Health

  • D-581-2013 Class II — Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, (May 15, 2013)
  • D-584-2013 Class II — Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate s (May 15, 2013)
  • D-592-2013 Class II — Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution w (May 15, 2013)
  • D-588-2013 Class II — Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution wit (May 15, 2013)
  • D-582-2013 Class II — Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysa (May 15, 2013)
  • D-595-2013 Class II — Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate s (May 15, 2013)
  • D-585-2013 Class II — IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino a (May 15, 2013)
  • D-583-2013 Class II — Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate s (May 15, 2013)
  • D-590-2013 Class II — Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with (May 15, 2013)
  • D-589-2013 Class II — Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with (May 15, 2013)