D-581-2013 Class II Terminated
FDA drug recall D-581-2013 was initiated by Pentec Health on May 15, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. The recall status is terminated (terminated December 16, 2014). Affected quantity: 1 Bag.
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
- 1 Bag
Product Description
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
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: 4/25/13 Discard after: 5/16/13