Reported Nov 30, 2016 · Terminated

Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per…

VistaPharm, Inc.

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: VistaPharm, Inc. · 7265 Ulmerton Rd · Largo, FL · 33771-4809

Is this the product you have?

  • Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Lot codes and dates
    • Lot No. 378300
    • Exp 11/16
Amount recalled
1497 cases

Where it was sold

  • Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.

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 24, 2021 · Data as of Sep 19, 6:23 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.