Reported Jan 20, 2021 · Ongoing
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC…
Sunstar Americas, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sunstar Americas, Inc. · 301 E Central Rd · Schaumburg, IL · 60195-1901
Is this the product you have?
- Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only
- packaged ina) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
- Lot codes and dates
ALL LOTS with expiration date from Dec. 312020 through Sep. 302022
- Amount recalled
- a) 1,021,914 bottles; b) 255,552 bottles
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
This product could cause temporary or reversible health problems — stop using it.
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