FDA Drug Class II — Moderate

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.

Hazard

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Products

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.
Brand
VistaPharm, Inc.
UPC
Lot No. 422800 (1Exp. 0/17), 430500 (Exp. 12/17), 424000 (Exp. 10/17), 412500 (Exp. 07/17), 405500 (Exp. 05/17), 414900 (Exp. 09/17)

Units Affected

18,437 unit dose cups