Reported Sep 30, 2015 · Terminated

0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter…

Baxter Healthcare Corporation

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: Baxter Healthcare Corporation · Road #144, #250 · Jayuya, PR · 00664-1503

Is this the product you have?

  • 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Lot codes and dates
    • Lot #: P329821
    • Exp 08/31/2016
Amount recalled
139,104 Bags

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.

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 Sep 15, 2016 · Data as of Sep 19, 5:54 PM UTC

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