FDA-Drug2020-12-02Class I
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.
Sunstar Americas, Inc.
Hazard
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Sold states
USA Nationwide
Affected count
a) 116,662 bottles; b) 13,296 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 (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2021Don't want to check this manually?
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