D-594-2013 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
- 8 Bags
Product Description
Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL 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: 04/24/13, 04/29/13 Discard after: 5/21/13, 05/22/13