PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 9, 2017 Initiated: June 26, 2017 #D-1053-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
VistaPharm, Inc.
Units Affected
9945 cases
Distribution
CA, IL, LA, NH, OH, PA, SC
Location
Largo, FL

Frequently Asked Questions

What product 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. Recalled by VistaPharm, Inc.. Units affected: 9945 cases.
Why was this product recalled?
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1053-2017.