D-1052-2017 Class II Terminated

Recalled by VistaPharm, Inc. — Largo, FL

Recall Details

Product Type
Drugs
Report Date
August 9, 2017
Initiation Date
June 26, 2017
Termination Date
April 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6150 cases

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018