Reported Jun 12, 2013 · Terminated

Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in…

Pentec Health

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pentec Health · 4 Creek Pkwy Ste A · Boothwyn, PA · 19061-3132

Is this the product you have?

5 of 5 products

Products covered by this recall
#Product as published
11000mL bag
22000mL bag
32500mL bag
45000mL bag, and
56000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
Lot codes and dates
  • Compounding Date
    • 04/24/13
    • 04/29/13
  • Discard after
    • 5/21/13
    • 05/22/13
Amount recalled
8 Bags

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 16, 2014 · Data as of Sep 19, 7:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.