D-589-2013 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
- 38 Bags
Product Description
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL 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 Discard after: 05/15/13