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.

Recall Number: D-0103-2021

Firm: Sunstar Americas, Inc.

Classification: Class I

Status: Completed

Report Date: 20201202

Initiation Date: 20201027

Termination Date:

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

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.