FDA Drug recall D-589-2013
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pente…
- FDA Drug
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pente… 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-589-2013 |
| 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
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL 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: 04/24/13 Discard after: 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-589-2013%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.