FDA recall D-0938-2017

Product

Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16

Reason for recall

CGMP Deviations

Distribution

Natiowide

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-07-12

Termination date

2018-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0938-2017