FDAFDA · Food and drugs·Recall number D-583-2013
Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL 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
- a) Compounding Date: 04/30/13 Discard After: 05/21/13 b) Compounding Date: 04/30/13 Discard After: 05/21/13 c) Compounding Date: 04/25/13, 04/30/13 Discard After: 05/16/13, 05/21/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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