FDA-Drug2021-01-20Class II
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
Sunstar Americas, Inc.
Hazard
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Sold states
Nationwide USA
Affected count
a) 1,021,914 bottles; b) 255,552 bottles
Manufactured in
301 E Central Rd, N/A, Schaumburg, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2021Don't want to check this manually?
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