D-585-2013 Class II Terminated
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
- 3 Bags
Product Description
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
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: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13