Drug product
Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132
D-581-2013
Product summary
- Firm
- Pentec Health
- Event
- Event 65180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 Bag
- Official record key
drug-enforcement:D-581-2013
Official wording
Reason: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Code information: Compounding Date: 4/25/13 Discard after: 5/16/13
Distribution pattern: Dialysis Centers Direct to patient
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility