FDAFDA · Food and drugs·Recall number D-585-2013
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Published June 12, 2013 · Recall initiated: May 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Pentec Health
- Distributor
- Dialysis Centers Direct to patient
- Lot
- Compounding Date: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.