# FDA recall D-582-2013

> **Pentec Health** · Class II · drug recall initiated 2013-05-15.

## Product

Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. 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

Dialysis Centers  Direct to patient

## Key facts

- **Recall number:** D-582-2013
- **Recalling firm:** Pentec Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-15
- **Report date:** 2013-06-12
- **Termination date:** 2014-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boothwyn, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-582-2013

## Citation

> AI Analytics. FDA recall D-582-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-582-2013. Source: US FDA. Licensed CC0.

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