FDA recall D-0463-2017

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-01-18

Report date

2017-02-08

Termination date

2021-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0463-2017