FDAOctober 27, 2020drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

What to do

FDA enforcement status: Completed

Brands named

sunstar americassunstar

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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