FDAFDA · Food and drugs·Recall number D-581-2013
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
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: 4/25/13 Discard after: 5/16/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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