Drug Safety Alerts

Paroex® Chlorhexidine Gluconate Oral Rinse, 0.12% Consumer-Level Recall

12/31/2020

On December 31, 2020, Precision Dose, Inc. issued a consumer-level recall of all lots of Chlorhexidine Gluconate Oral Rinse, 0.12% with an expiration date from 1/31/2021 through 2/28/2022. This recall was issued because the product may be contaminated with the bacteria Burkholderia lata.

A complete list of the affected products and lot numbers can be found here.

From information provided by the manufacturer, Sunstar Americas, Inc., use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy, and in the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

• Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-0028-62, NDC 68094-0028-59

• Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-0028-61, NDC 68094-0028-59

This may represent a health hazard or safety risk to patients using product affected by this recall.

Precision Dose, Inc. advises that patients should stop using their Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% supplied by Precision Dose, Inc. immediately. Patients should call their healthcare provider further guidance and/or a replacement prescription.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Precision Dose, Inc. at 1-800-397-9228, Monday through Friday from 8:00 AM to 4:30 PM (CST) or email customercare@precisiondose.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.