Lactulose Solution recalled over sterility concerns

Recall date

June 26, 2017

Source

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

Official notice title

VistaPharm, Inc. recalls Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by Vist…

Recall number

D-1053-2017

FDA classification

Class II

Brand / firm

VistaPharm, Inc.

Sold / distributed

CA, IL, LA, NH, OH, PA, SC

Why it was recalled

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

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, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01