Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate Recalled by Pentec Health Due to Lack of Assurance of Sterility: Sterility could not...

Date: May 15, 2013
Company: Pentec Health
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pentec Health directly.

Affected Products

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Quantity: 4 Bags

Why Was This Recalled?

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

Where Was This Sold?

Dialysis Centers Direct to patient

About Pentec Health

Pentec Health has 15 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report