Drug product
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132
D-586-2013
Product summary
- Firm
- Pentec Health
- Event
- Event 65180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 Bags
- Official record key
drug-enforcement:D-586-2013
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