Lactulose Solution recalled over sterility concerns

Recall date

November 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

VistaPharm, Inc. recalls 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…

Recall number

D-0146-2017

FDA classification

Class II

Brand / firm

VistaPharm, Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.