Sunstar Americas, Inc., Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%, for Microbial Contamination
On December 28, 2020, the U.S. Food and Drug Administration (FDA) announced that Sunstar Americas, Inc. (SAI), expanded its October 27, 2020, voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse]) of Paroex® chlorhexidine gluconate oral Rinse USP, 0.12%, because of possible contaminated with the bacteria Burkholderia lata.
Use of the defective product in immunocompromised patients may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.
SAI received reports of 29 adverse events to date. Affected patients tested positive for B. lata infections, which were typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with preexisting respiratory conditions, including those infected with the COVID-19 coronavirus, is particularly unsafe.
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. It is distributed across the United States to dental offices, dental distributors, pharmaceutical wholesalers, dental schools, and pharmacies in the following packages:
- 1789P GUM® Paroex® is distributed in cases each containing six amber bottles of 16 fl. oz. (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wraparound label.
- 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fl. oz. (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wraparound label.
The following products and lots are affected:
Paroex® chlorhexidine gluconate oral rinse USP, 0.12%
- 16 fl. oz. amber bottles
- NDC #: 052376-021-02
- Product code: 1789P
- All lots with expiration dates from December 31, 2020–September 30, 2022
Paroex® chlorhexidine gluconate oral rinse USP, 0.12%
- 4 fl. oz. amber bottles
- NDC #: 052376-021-04
- Product Code: 1788P
- All lots with expiration dates from December 31, 2020–September 30, 2022
Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. SAI notified its direct distributors and customers and is arranging for return of all recalled products. Consumers should contact their physician or healthcare provider with any problems that may be related to using this drug product. Consumers can contact SAI with other questions by phone at 800-528-8537 or email us.pcr@us.sunstar.com (mailto:us.pcr@us.sunstar.com) Monday–Friday from 8 am–5 pm CST.
Healthcare providers should report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda), mail (https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting), or fax (800-FDA-0178).