December 04, 2016
Nearly 1500 cases of Lactulose Solution, USP, 10 g/15 mL, have been recalled by its manufacturer.
VistaPharm, Inc, voluntarily initiated the ongoing, Class II recall on November 9.
The recall is being attributed to the “Microbial Contamination of Non-Sterile Products,” according to the US Food and Drug Administration (FDA) Enforcement Report for the week of November 30. More specifically, “bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia” the report stated.
The FDA defines a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The recall includes Lactulose Solution that was distributed across the country and packaged in 15-mL unit dose cups (NDC 66689-039-01), with 50 unit dose cups per case (NDC 66689-039-50). The code information for the impacted product is as follows: Lot No. 378300, Exp 11/16.
Lactulose Solution is indicated for the treatment of constipation.—Meredith Edwards White