FDA Drug Class II — Moderate

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

Hazard

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

Products

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
Brand
VistaPharm, Inc.
UPC
Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018

Units Affected

6150 cases