Fresenius bag 1% Amino Acids — Class II drug recall D-584-2013
Terminated recall by Pentec Health, reported 2013-06-12. Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescr
| Recall number | D-584-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentec Health, Boothwyn, PA, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-06-06 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-12-16 |
| Quantity | 1 bags |
| Reason classes | sterility |
Product
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.