Chlorhexidine Gluconate Oral Rinse 0.12% (Paroex®) Recall Due to Possible Microbial Contamination

FDA recently posted an announcement regarding chlorhexidine gluconate 0.12% oral rinse used as a prescription-only antimicrobial product indicated for the treatment of gingivitis and periodontitis. Sunstar Americas Inc. (SAI) issued a voluntary recall of specific lots of chlorhexidine gluconate 0.12% oral rinse with an expiration date between 6/30/2022 – 9/30/2022 due to possible bacterial contamination with Burkholderia lata. Use of the recalled product may result in infections requiring antibiotic therapy, or in an immunosuppressed host, may lead to a life-threatening infection including bacteremia or pneumonia. Lohxa, LLC issued a similar recall on specific lots of alcohol free chlorhexidine gluconate 0.12% oral rinse with an expiration date between 01/31/21 – 03/31/21. This product is sourced and repackaged from SAI.

To date, no adverse reactions have been reported related to the use of the recalled product. SAI notified its customers and distributors by mail and requested for the recalled products to be returned. Patients, pharmacies, and healthcare facilities are advised to stop using and dispensing affected lots immediately.

Consumers should contact their health care provider if they have experienced any adverse effects while using this product. Call (SAI: 1-800-528-8537, Lohxa, LLC 1-800-641-5564) or email (SAI: us.pcr@us.sunstar.com, Loxha, LLC: info@lohxa.com) with questions regarding the recall. Health care providers and patients are encouraged to report adverse events to the FDA MedWatch program in 1 of 2 ways.

  1. Submit a report online at www.fda.gov/medwatch/report.htm
  2. Complete a paper form and fax to 1-800-FDA-0178

Copyright 2020, Drug information Service, University of Utah, Salt Lake City, UT.