FDA recall D-0103-2021

Product

Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.

Reason for recall

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Distribution

USA Nationwide

Key facts

Status

Completed

Initiation date

2020-10-27

Report date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2021