VistaPharm, Inc. recalls Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL
Recalled February 8, 2017 · FDA recall D-0463-2017 · VistaPharm
Hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. · FDA Class II
Units
7,404 unit dose cups
Sold at
Nationwide
Description
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Product
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
Manufacturer(s)
VistaPharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →