FDA Drug recall D-585-2013
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec…
- FDA Drug
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec… by Pentec Health, citing lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-585-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-15 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pentec Health |
| Distribution | n/a |
Product
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Reason
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Identifiers
| code_info | Compounding Date: a) 04/25/13, b) 04/24/13 Discard After: a) 05/20/13, b) and c) 05/15/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-585-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.