Sunstar Americas, Inc. recalls Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-
Recalled January 20, 2021 · FDA recall D-0222-2021 · Sunstar Americas
Hazard
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions · FDA Class II
Units
a) 1,021,914 bottles; b) 255,552 bottles
Sold at
Nationwide USA
Description
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Product
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., Schaumburg, IL
Manufacturer(s)
Sunstar Americas, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →