D-588-2013 Class II Terminated
FDA drug recall D-588-2013 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: 59 Bags.
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
- 59 Bags
Product Description
Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL 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: 04/23/13, 04/24/13, 04/29/13, 05/01/13 Discard after: 05/20/13, 05/22/13