Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
Recall Number: D-0462-2017
Firm: VistaPharm, Inc.
Classification: Class II
Status: Terminated
Report Date: 20170208
Initiation Date: 20170118
Termination Date: 20210826
Reason for Recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product Description
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.