Sunstar Americas, Inc.

Schaumburg, IL, United States

2

Total Recalls

1

Class I Recalls

1

Ongoing Recalls

Recalls by Sunstar Americas, Inc.

FDA Drug Class II Ongoing

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumbur

December 28, 2020 Sunstar Americas, Inc. a) 1,021,914 bottles; b) 255,552 bottles units

FDA Drug Class I Completed

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.

October 27, 2020 Sunstar Americas, Inc. a) 116,662 bottles; b) 13,296 bottles units