Drug product
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
D-589-2013
Product summary
- Firm
- Pentec Health
- Event
- Event 65180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 Bags
- Official record key
drug-enforcement:D-589-2013
Official wording
Reason: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Code information: Compounding Date: 04/24/13 Discard after: 05/15/13
Distribution pattern: Dialysis Centers Direct to patient
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility