FDA recall D-1053-2017

Product

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-06-26

Report date

2017-08-09

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1053-2017