Sunstar Americas, Inc. recalls Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 5237
Recalled December 2, 2020 · FDA recall D-0103-2021 · Sunstar Americas
Hazard
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. · FDA Class I
Units
a) 116,662 bottles; b) 13,296 bottles
Sold at
USA Nationwide
Description
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
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.
Manufacturer(s)
Sunstar Americas, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →