D-584-2013 Class II Terminated
FDA drug recall D-584-2013 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
Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL 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: 04/30/13 Discard after: 05/21/13